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

Model Number	26775C
Medical Device Problem Codes	Melted (1385); 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
This mdr was created to correct the internal notification number from the previous supplemental report submitted for this event.The correct notification number is (b)(4).
Additional Manufacturer Narrative
This notification (b)(4) is closed.New information was received stating that only two devices were involved in two separate events.These events are reported under karl storz reference numbers (b)(4), with mdrs 9610617-2024-00059 & 9610617-2024-00063.".

• 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: 18870988
• Report Number: 9610617-2024-00064
• Device Sequence Number: 18089229
• 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,Followup
• Report Date (Section B): 04/02/2024

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: 03/19/2024; 03/19/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/26/2024; 04/02/2024
• 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