MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR

Model Number	011160-10
Medical Device Problem Code	Break (1069)
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 returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
In the transurethral resection of the prostate procedure, the mentioned material broke.Therefore, a second units was used.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information: the device in question was not returned to karl storz tuttlingen.Therefore, a technical and a final determination of the root cause is not possible.In similar cases with the same product, excessive force during application caused the electrode wire to break.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Common Device Name: ELECTRODE, BIPOLAR
• 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: 22439562
• Report Number: 9610617-2025-01152
• Device Sequence Number: 4745771
• Product Code: FAS
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 854217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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