ELECTRODE, BIPOLAR
Received Apr 21, 2026 · Event occurred Mar 13, 2026
Report 2020550-2026-00664 · MDR key 24945593
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Se & Co. KgModel number
011160-01Catalog number
011160-01
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "ON (B)(6) 2026, DURING AN OPERATIVE HYSTEROSCOPY FOR THE REMOVAL OF A SUBMUCOSAL UTERINE MYOMA OF "STANDARD" CONSISTENCY, IT BECAME NECESSARY TO REPLACE THE SINGLE USE STORZ BIPOLAR LOOP ELECTRODE (REF. 011160-01, LOT 863055, EXPIRY DATE 20230630) TWICE. DURING THE PROCEDURE, A SPONTANEOUS BREAKAGE OCCURRED, ASSOCIATED WITH A CONSEQUENT AND SIGNIFICANT ELECTRICAL DISCHARGE. THE LOOP BROKE AFTER ONLY A FEW MINUTES OF USE AND CAUSED AN ELECTRICAL DISCHARGE TWICE. WITH THE THIRD LOOP, THEY DID NOT EXPERIENCE ANY ISSUES. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS USING THE THIRD LOOP". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NEW INFORMATION RECEIVED: THERE WAS A PROLONGATION OF PROCEDURE OF 90 MINUTES. DUE TO THAT, A REPORT IS REQUIRED.