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: KNS
FDA class 2
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Adverse events in period
3,090
+40% vs. prior period (2,205)
Deaths reported
24
Recalls in period
51
Class I enforcement
6
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
24
16
Injury
1,056
694
Malfunction
2,010
1,495
Most reported coded problems
Top 15Product problems
Count
Break
1,158
Adverse Event Without Identified Device or Use Problem
1,131
Detachment of Device or Device Component
191
Use of Device Problem
180
Positioning Failure
103
Material Deformation
96
Positioning Problem
82
Activation Failure
82
Activation, Positioning or Separation Problem
78
Deformation Due to Compressive Stress
77
Device Contaminated During Manufacture or Shipping
71
Material Separation
53
Fracture
50
Peeled/Delaminated
48
Device Contamination with Chemical or Other Material
47
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
2,213
Hemorrhage/Blood Loss/Bleeding
198
Urinary Retention
184
Urinary Tract Infection
180
Hematuria
160
Perforation
97
Micturition Urgency
83
Dysuria
70
Inflammation
69
Unspecified Infection
59
Pain
57
Fever
56
Foreign Body In Patient
51
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
49
Insufficient Information
44
Recalls in period
51 total
FDA enforcement classification:
Class I: 6
Class II: 45
Date
Recalling firm
Status
Reason
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07
Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-19
Open, Classified
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or
expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
2025-12-18
Open, Classified
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
2024-12-20
Open, Classified
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Adverse events by year
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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 KNS, 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: 2026-07-06 01:15 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.