n.a. 28160GERecalls & reported problems
Karl Storz GmbH & Co. KG · Working Insert · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551234341), received between May 20, 2020 and May 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Solder Joint Fracture” (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.
Most reported problems
Device problems
- Solder Joint Fracture1
Patient problems
- Brain Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2020Solder Joint Fracture; Solder Joint Fracture
AS PER A REPORT WE RECEIVED FROM THE FACTORY IN (B)(4) REGARDING AN EVENT THAT TOOK PLACE IN (B)(6): HANDLING DIFFICULT DURING OPERATION; WELD PROBLEM ON THE THREE-WAY STOP COCK. DAMAGE TO THE LEFT SIDE OF THE BRAIN POSTOPERATIVE.
Patient problems: Brain Injury
MAUDE report 10076824 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.