ELECTRODE, BIPOLAR

Additional Manufacturer Narrative

*NEW INFORMATION RECEIVED UPGRADED THE EVENT TO ADVERSE EVENT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

NEW INFORMATION RECEIVED: THERE WAS A PROLONGATION OF PROCEDURE OF 90 MINUTES. DUE TO THAT, A REPORT IS REQUIRED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. 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).

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.