ELECTRODE, BIPOLAR
Received Jun 3, 2026
Report 9610617-2026-01275 · MDR key 25382684
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011160-10Catalog number
011160-10
Lot number
NOC
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT ELECTRODE INCOMPLETE AT DISTAL END - CUSTOMER STAFF UNAWARE IF THE DAMAGE HAPPENED DURING PROCEDURE OR NOT. NO KNOWN INCIDENT REPORT RAISED SO WE ARE UNAWARE IF THE ITEM WAS DAMAGED IN CASE OR NOT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.