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

Model Number	26158BE
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The foit was reported that there was a breakage of the bipolar electrode in the first intervention.The surgical procedure was delayed for 5 minutes and the bipolar electrode was removed with forceps.No harm to patient, user or third parties reported.
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).
Additional Manufacturer Narrative
Device evaluation: no item was sent to karl storz tuttlingen; therefore, no physical inspection of the item could be carried out.The customer has forwarded pictures in the correspondence.Based on these pictures and the customer's description, it can be concluded that this damage was caused by overloading the item.Based on our experience, this damage may have been caused by too high a force or too long a voltage spike.The corresponding ifu 97000057 ; version : v2.0 - 10/2017 points out that the instrument must be checked before and after every use.Furthermore, the device history records have been checked and found to be according to the specificationm, valid at the time of production.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIPOLAR VAPORIZATION ELECTRODE
• Common Device Name: BIPOLAR VAPORIZATION ELECTRODE
• 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: 19730688
• Report Number: 9610617-2024-00215
• Device Sequence Number: 15526310
• Product Code: GCJ
• UDI-Device Identifier: 04048551094204
• UDI-Public: 04048551094204
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951986
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 26158BE
• Device Catalogue Number: 26158BE
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (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