n.a. 11003MARecalls & reported problems
Karl Storz GmbH & Co. KG · Biopsy Forceps, flexible, 1 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551050248), received between Jul 16, 2025 and Jul 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Mechanical Problem; Mechanical Problem
THE FOLLOWING WAS REPORTED, WHILE ATTEMPTING TO PERFORM A TRACHEOBRONCHIAL MUCOSAL BIOPSY, THE FORCEPS LOST ITS MOVEMENT, MAKING ITS USE IMPOSSIBLE. THE PROCEDURE WAS CANCELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. DUE TO THE PROLONGATION OF THE PROCEDURE LONGER THAN 60 MINUTES AND THE CANCELED PROCEDURE THE EVENT IS DEEMED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524217 ↗InjuryJul 16, 2025Mechanical Problem; Mechanical Problem
THE FOLLOWING WAS REPORTED; WHILE ATTEMPTING TO PERFORM A TRACHEOBRONCHIAL MUCOSAL BIOPSY, THE FORCEPS LOST ITS MOVEMENT, MAKING ITS USE IMPOSSIBLE. THE PROCEDURE WAS CANCELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. DUE TO THE PROLONGATION OF THE PROCEDURE LONGER THAN 60 MINUTES AND THE CANCELED PROCEDURE THE EVENT IS DEEMED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524215 ↗
Other BRONCHOSCOPE (FLEXIBLE OR RIGID) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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