Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: GEI
FDA class 2
Electrosurgical, Cutting & Coagulation & Accessories
Adverse events in period
14,398
-1% vs. prior period (14,524)
Deaths reported
34
Recalls in period
52
Class I enforcement
10
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
34
50
Injury
2,275
2,634
Malfunction
12,055
11,827
Other
34
10
Not specified
0
3
Most reported coded problems
Top 15Product problems
Count
Detachment of Device or Device Component
1,420
Adverse Event Without Identified Device or Use Problem
1,364
Break
1,228
Energy Output Problem
1,066
Communication or Transmission Problem
937
Electrical /Electronic Property Problem
932
Peeled/Delaminated
868
Difficult to Open or Close
629
Intermittent Energy Output
447
Output Problem
419
Insufficient Device Problem Information
376
Material Twisted/Bent
353
Failure to Deliver Energy
346
Overheating of Device
325
Self-Activation or Keying
316
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
10,942
Insufficient Information
963
Burn(s)
709
Hemorrhage/Blood Loss/Bleeding
684
Foreign Body In Patient
209
Superficial (First Degree) Burn
188
Partial thickness (Second Degree) Burn
185
Full thickness (Third Degree) Burn
125
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
109
Thrombosis/Thrombus
102
Unspecified Tissue Injury
97
Pain
90
Erythema
73
Blister
69
Electric Shock
65
Recalls in period
52 total
FDA enforcement classification:
Class I: 10
Class II: 42
Date
Recalling firm
Status
Reason
2026-03-23
Open, Classified
Potential for detachment of a distal tip component of the device during use.
2026-03-23
Open, Classified
Potential for detachment of a distal tip component of the device during use.
2026-03-23
Open, Classified
Potential for detachment of a distal tip component of the device during use.
2026-03-23
Open, Classified
Potential for detachment of a distal tip component of the device during use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2026-02-25
Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
2025-10-31
Open, Classified
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
2025-10-31
Open, Classified
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
2025-10-31
Open, Classified
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
2025-09-04
Open, Classified
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
2025-08-21
Open, Classified
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
2025-08-06
Open, Classified
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
2025-07-25
Open, Classified
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
2025-07-25
Open, Classified
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
2025-03-20
Open, Classified
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
2025-03-10
Open, Classified
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
2025-03-05
Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
2025-03-05
Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
2025-03-05
Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
2025-03-05
Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
2025-01-08
Open, Classified
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
2025-01-08
Open, Classified
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
2024-12-09
Open, Classified
Potential for two issues:
1. Bent or detached heater wire;
2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
2024-12-09
Open, Classified
Potential for two issues:
1. Bent or detached heater wire;
2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
2024-12-03
Open, Classified
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-14
Open, Classified
Potential for the outer stainless-steel tube to break or detach.
2024-11-12
Open, Classified
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
2024-11-05
Open, Classified
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-10-04
Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents
carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
2024-09-20
Open, Classified
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
2024-09-17
Open, Classified
A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
2024-09-04
Open, Classified
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
2024-09-04
Open, Classified
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
2024-07-01
Open, Classified
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
2024-07-01
Open, Classified
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
2024-07-01
Open, Classified
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Adverse events by year
Loading...
Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code GEI, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-05 20:31 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.