ELECTRODE, BIPOLAR
Received Jun 12, 2026 · Event occurred May 19, 2026
Report 2020550-2026-01365 · MDR key 25488965
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011050-10Catalog number
011050-10
Lot number
864961
Product problems
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING ACTIVATION OF THE BIPOLAR LOOP TO REMOVE THE ENDOCERVICAL POLYP, A SUDDEN FLASH OF LIGHT OCCURRED, CAUSING THE LOOP TO BREAK. THE HYSTEROSCOPY PROCEDURE WAS IMMEDIATELY SUSPENDED. ENDOCERVICAL POLYPECTOMY COMPLETED USING FORCEPS DUE TO TORSION. THE OUTPATIENT PROCEDURE WAS CONVERTED TO INPATIENT ADMISSION TO PERFORM AN ABDOMINAL X-RAY TO RULE OUT THE PRESENCE OF A FOREIGN BODY. X-RAY RESULTS WERE NEGATIVE FOR A FOREIGN BODY.
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)