BEUDAMED

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

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Product Code: EOQ FDA class 2

Bronchoscope (Flexible Or Rigid)

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Adverse events in period

14,155

+51% vs. prior period (9,401)

Deaths reported

72

Recalls in period

35

Class I enforcement

24

Adverse events per month

2024-07 – 2026-06

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Events by type

Period vs. prior period

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Event type

Period

Prior

Death

72

54

Injury

1,208

1,140

Malfunction

12,875

8,207

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Most reported coded problems

Top 15

Product problems

Count

No Display/Image

3,943

Communication or Transmission Problem

1,840

Poor Quality Image

1,061

Erratic or Intermittent Display

1,056

Thermal Decomposition of Device

933

Adverse Event Without Identified Device or Use Problem

860

Detachment of Device or Device Component

801

Peeled/Delaminated

703

Break

446

Failure to Clean Adequately

424

Degraded

416

Corroded

371

Display or Visual Feedback Problem

254

Device Reprocessing Problem

242

Melted

191

Patient problems

Count

No Clinical Signs, Symptoms or Conditions

13,042

Pneumothorax

527

Hemorrhage/Blood Loss/Bleeding

161

Insufficient Information

110

Cardiac Arrest

67

Foreign Body In Patient

66

Unspecified Infection

33

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

30

Stroke/CVA

27

Bacterial Infection

26

Myocardial Infarction

20

Subclinical Infection

18

Low Blood Pressure/ Hypotension

17

Fungal Infection

17

Respiratory Failure

16

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Recalls in period

35 total

FDA enforcement classification: Class I: 24 Class II: 12

Date

Recalling firm

Status

Reason

2026-01-29

Olympus Corporation of the Americas

Open, Classified

Potential for rubber fragment detachment during use.

2026-01-29

Olympus Corporation of the Americas

Open, Classified

Potential for rubber fragment detachment during use.

2026-01-21

Auris Health, Inc

Open, Classified

Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.

2025-12-04

Intuitive Surgical, Inc.

Open, Classified

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

2025-09-12

Noah Medical Corporation

Open, Classified

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-09-11

Olympus Corporation of the Americas

Open, Classified

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

2025-04-07

Ambu Inc.

Open, Classified

Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.

2025-01-15

Olympus Corporation of the Americas

Open, Classified

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

2024-10-28

Noah Medical

Open, Classified

Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

2024-10-25

Noah Medical

Open, Classified

Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.

2024-10-25

Noah Medical

Open, Classified

Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

2024-08-02

AURIS HEALTH INC

Open, Classified

Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

2024-07-12

Intuitive Surgical, Inc.

Open, Classified

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

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Adverse events by year

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Methodology & data provenance

For your PSUR appendix

Search protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code EOQ, 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 23:24 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.

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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.