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

Model Number	277KB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, the cable was being used during a urological procedure.While using, the cable snapped and a loud explosion was witnessed by the team present inside the theatre.No death or (unanticipated) serious deterioration in state of health reported.

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• 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: 23884897
• Report Number: 9610617-2025-02430
• Device Sequence Number: 9650504
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: 04048551090169
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 12/23/2025

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: 277KB
• Device Catalogue Number: 277KB
• Device Lot Number: NS01
• 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: 12/08/2025
• Initial Report FDA Received Date: 12/23/2025
• 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