n.a. 26160SHWRecalls & reported problems
Karl Storz GmbH & Co. KG · Scissors, 5 Fr. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551094655), received between Jul 14, 2023 and Aug 12, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Crack2
- Material Fragmentation2
- Pitted1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227621 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT'S BEAK BREAKS. NO PATIENT INVOLVEMENT AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677905 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED THAT THE BLADE OF THE SCISSORS HAS COME LOOSE. NO PATIENT INVOLVEMENT AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179975 ↗InjuryJul 14, 2023Crack; Material Fragmentation; Crack; Material Fragmentation
IT WAS REPORTED THAT FRAGMENT WAS IDENTIFIED IN THE UTERUS WHEN VIEWED ON THE MONITOR DURING THE CERVICAL PROCEDURE WITH THE 26160SHW(ZP02). THE PROCEDURE WAS DELAYED TO IDENTIFY AND REMOVE THE DEBRIS; HOWEVER, THE DEBRIS WAS VERY FINE AND COULD NOT BE REMOVED. THERE HAS BEEN NO IMPACT ON THE PATIENT SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17326739 ↗InjuryJul 14, 2023Crack; Material Fragmentation; Pitted; Crack; Material Fragmentation; Pitted
IT WAS REPORTED THAT FRAGMENT WAS IDENTIFIED IN THE UTERUS WHEN VIEWED ON THE MONITOR DURING THE CERVICAL PROCEDURE WITH THE 26160SHW(ZP02). THE PROCEDURE WAS DELAYED TO IDENTIFY AND REMOVE THE DEBRIS; HOWEVER, THE DEBRIS WAS VERY FINE AND COULD NOT BE REMOVED. THERE HAS BEEN NO IMPACT ON THE PATIENT SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17326738 ↗
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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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