MalfunctionFAS
ELECTRODE, BIPOLAR
Received Mar 16, 2026 · Event occurred Feb 28, 2026
Report 9610617-2026-00574 · MDR key 24613568
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
862169
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT BY ANOTHER LOOP FROM THE SAME LOT.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WILL NO BE RETURNED TO MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).