n.a. 26153BIRecalls & reported problems
Karl Storz GmbH & Co. KG · BETTOCCHI Inner Sheath · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551230169), received between Dec 3, 2025 and Apr 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Material Separation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE LOCKING MECHANISM DISMANTLES DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818984 ↗MalfunctionApr 8, 2026Material Separation
IT WAS REPORTED THAT "DURING THE PROCEDURE, THE LOCKING MECHANISM DISMANTLES DURING USE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817865 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, THE WORKING CHANNEL OF 26153BI WAS BROKEN DURING OPERATION. A NEW 26153BI WAS THEN OPENED TO COMPLETE THE PROCEDURE . NO INJURY TO PATIENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710243 ↗
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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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