n.a. 28160EKRecalls & reported problems
Karl Storz GmbH & Co. KG · Scissors, 1.3 mm, semi-rigid · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551096642), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A "VENTRICULOCISTERNOSTOMY" SURGICAL PROCEDURE, THE "SCISSORS WITH ONE MOVABLE JAW," WHICH WERE FUNCTIONAL AT THE BEGINNING OF THE OPERATION, BECAME NON-FUNCTIONAL MIDWAY THROUGH THE PROCEDURE: THEY APPEARED TO NO LONGER OPEN AND WERE THEREFORE REMOVED FROM THE SURGICAL FIELD. DURING THE REPROCESSING PHASE AT THE TIME OF PRE-DISINFECTION, IT WAS DISCOVERED THAT ONE OF THE SCISSOR BLADES WAS MISSING. POSTOPERATIVE REVIEW OF THE PROCEDURE VIDEO: "NO BREAKAGE OF THE DEVICE IS VISIBLE IN THE VENTRICULAR CAVITIES". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333230 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.