n.a. 10378HFRecalls & reported problems
Karl Storz GmbH & Co. KG · Optical Forceps, alligator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551047613), received between May 11, 2018 and Mar 11, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2026Break
THE FOLLOWING WAS REPORTED: "DURING A BRONCHOSCOPY, THE INSTRUMENTS WERE DAMAGED TRYING TO REMOVE A FOREIGN OBJECT. DUE TO THE COMPLEXITY OF THE CASE EXTRA FORCE WAS REQUIRED, WHICH IS WHY WE BELIEVE THE INSTRUMENTS WERE DAMAGED. CASE ABORTED DUE TO COMPLEXITY, NOT THE KIT. THE CASE WAS A DIFFICULT BRONCHOSCOPY WHERE THE PATIENT HAD A THUMB PIN STUCK IN THEIR AIRWAY. THE PIN WAS LODGED IN THE PATIENT AND POTENTIALLY TOO HEAVY FOR THE GRASPER, CAUSING THE GRASPER TO BREAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576043 ↗InjuryMar 11, 2026Break
THE FOLLOWING WAS REPORTED: "DURING A BRONCHOSCOPY, THE INSTRUMENTS WERE DAMAGED TRYING TO REMOVE A FOREIGN OBJECT. DUE TO THE COMPLEXITY OF THE CASE EXTRA FORCE WAS REQUIRED, WHICH IS WHY WE BELIEVE THE INSTRUMENTS WERE DAMAGED. CASE ABORTED DUE TO COMPLEXITY, NOT THE KIT. THE CASE WAS A DIFFICULT BRONCHOSCOPY WHERE THE PATIENT HAD A THUMB PIN STUCK IN THEIR AIRWAY. THE PIN WAS LODGED IN THE PATIENT AND POTENTIALLY TOO HEAVY FOR THE GRASPER, CAUSING THE GRASPER TO BREAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576040 ↗MalfunctionMay 11, 2018Material Separation; Material Separation
ALLEGEDLY, DURING A FOREIGN BODY EMOVAL PROCEDURE TO REMOVE A COIN, ONE OF THE JAWS BROKE OFF OF THE INSTRUMENT INTO THE PATIENT'S ESOPHAGUS. THE BROKEN PIECE WAS RETRIEVED, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7509236 ↗
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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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