MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIPOLAR HIGH FREQUENCY CORD, 300 CM; Resectoscope

Model Number	277KB
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that when using the monopolar resectoscope, the cutting function was intermittently working, the coagulation function was working fine.On re-attempt of using the cutting function the diathermy cable near its connection to the resectoscope sparked and the cable broke.This happened towards the end of the procedure.Therefore, the fibroid had been completely resected.The procedure was stopped immediately and the resectoscope was removed.The patient did not come to any harm thankfully.The procedure was completed successfully.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The most probable root cause for the defect of the cable is the excessive mechanical stress on the cable after the bend protection.The cable was mechanically damaged at this point and when the hf device was activated, the contact resistance at this point became far too high and the cable became very hot very quickly.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: Resectoscope
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21274629
• Report Number: 9610617-2025-00090
• Device Sequence Number: 18181823
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 277KB
• Device Catalogue Number: 277KB
• Device Lot Number: TBC
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 04/03/2025; 09/04/2026
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/27/2025; 04/30/2025; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown