InjuryFAS
ELECTRODE, UNIPOLAR, POINTED
Received Oct 30, 2024 · Event occurred Oct 11, 2024
Report 2020550-2024-00426 · MDR key 20569743
Device
Generic name
Electrode, Unipolar, Pointed
Manufacturer
Karl Storz Se & Co. KgModel number
011111-10Catalog number
011111-10
Lot number
851098
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Electric Shock
- Insufficient Information
- Electric Shock
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT WHIST USING THE CUT FUNCTION, THE ELECTRODE LOOP BROKE APART. THE PHYSICIAN ALSO REPORTED WHEN THIS OCCURRED, HE FELT AN ELECTRIC SHOCK. HOWEVER, THE REPORTER SAID THIS WAS UNLIKELY AS THE PHYSICIAN WAS SCRUBBED AND WEARING GLOVES.