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

Model Number	26775C
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
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.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that "the proximal parts are charred, which creates sparks during their use".According to further received information there was a surgical delay of less than 15 minutes, but the procedure was successfully completed and there was no affect on a patient, user or third.
Additional Manufacturer Narrative
The affected item was not returned.Therefore, a physical investigation was not possible.A most probable cause was determined based on the available event information and the received photo of the affected item.Based on the error description and the photo sent in by the customer, the most probable cause is a potential user error / fault.It is visible on the photo that the electrode is severely scorched at the distal end, which is due to excessive heat.The most probable reason for this could be that the electrode was operated for too long or with a too high voltage.The instructions for use clearly state, that the instrument is intended for a recurring peak voltage of max.3.0kvp and only suitable for the short-term coagulation.However, as no product was sent in, a more detailed investigation cannot be carried out.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE
• Common Device Name: 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: 18870985
• Report Number: 9610617-2024-00059
• Device Sequence Number: 15400207
• Product Code: GEI
• UDI-Device Identifier: 04048551072288
• UDI-Public: 4048551072288
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944796
• 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): 05/31/2024

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: 26775C
• Device Catalogue Number: 26775C
• Device Lot Number: WM02
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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