BETTOCCHI 26153BORecalls & reported problems
Karl Storz GmbH & Co. KG · BETTOCCHI® Outer Sheath · Class 2
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 04048551230176), received between Sep 1, 2023 and Sep 1, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation2
- Corroded1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2023Corroded; Material Fragmentation; Corroded; Material Fragmentation
IT WAS REPORTED THAT METAL FRAGMENTS AND RUST CAME OFF FROM THE INSTRUMENTS WHILE DOING A HYSTEROSCOPY AND POLYPECTOMY CASE. SOME METAL FRAGMENTS WERE RECOVERED, BUT SOME FRAGMENTS COULD BE STILL INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17671449 ↗InjurySep 1, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT METAL FRAGMENTS AND RUST CAME OFF FROM THE INSTRUMENTS WHILE DOING A HYSTEROSCOPY AND POLYPECTOMY CASE. SOME METAL FRAGMENTS WERE RECOVERED, BUT SOME FRAGMENTS COULD BE STILL INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17671448 ↗
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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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