n.a. 50173AMRecalls & reported problems
Karl Storz GmbH & Co. KG · Suture Passer · Class 1
Data updated Oct 13, 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 04048551170076), received between Feb 11, 2026 and Feb 11, 2026 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
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.
InjuryFeb 11, 2026Break
IT WAS REPORTED THAT THE CUSTOMER WAS USING A SUTURE PASSER INSTRUMENT DURING A LAPAROSCOPIC APPENDECTOMY AND THE TIP BROKE INSIDE THE TISSUE OF THE ABDOMINAL WALL. THE TIP WAS REMOVED FROM THE PATIENT USING C-ARM GUIDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317432 ↗InjuryFeb 11, 2026Break
IT WAS REPORTED THAT THE CUSTOMER WAS USING A SUTURE PASSER INSTRUMENT DURING A LAPAROSCOPIC APPENDECTOMY AND THE TIP BROKE INSIDE THE TISSUE OF THE ABDOMINAL WALL. THE TIP WAS REMOVED FROM THE PATIENT USING C-ARM GUIDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317430 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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