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

Model Number	011110-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will not return the device for evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that during a bladder tumor resection the electrode broke.No negative impact in state of health reported.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the device was not sent to the karl storz assessment and repair department for inspection.No technical inspection could be performed, the error description provided by the customer, "011110-10 electrode broke in a case", could not be confirmed.Reviewing similar complaints of the same article code, it is most likely that the electrode got exposed to excessive force during application.A precise analysis of the cause cannot be carried out at present, as the item mentioned has not been made available to us as they were discarded by the customer.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.This event is filed under internal complaint id (b)(4).

• Brand Name: ELECTRODE, UNIPOLAR, ANGLED
• Common Device Name: ELECTRODE, UNIPOLAR, ANGLED
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22004846
• Report Number: 9610617-2025-00831
• Device Sequence Number: 9042514
• Product Code: FAS
• UDI-Device Identifier: 04048438000175
• UDI-Public: 04048438000175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K232486
• 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): 02/12/2026

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: 011110-10
• Device Catalogue Number: 011110-10
• Device Lot Number: 853647
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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