MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION AND DISSECTING ELECTRODE; MONOPOLAR L-SHAPE

Model Number	26775UF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was evaluated.The complaint is confirmed there is discoloration at the distal end, a whitish color and there is tearing of the insulation where it meets the metal hook at the distal end.The product failed the hi pot test indicating failure of the insulation along the shaft distal end.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).The ifu im-000001 ifu v 10.0 (10-2018) warns to inspect all insulated instruments prior to and after each procedure.Any damage to the insulation along the shaft of the instrument, such as dents, scratches, burns, cracking or splitting, may allow electrical current to leak and cause electrical shocks or burns to the patient.
Event or Problem Description
It was reported that there was event with 26775uf coagulating and dissecting electrode.According to the information received from the facility the electrode "burns the patient".There was no burn mark or leison left on the patient per facility as of the date of this report.
Additional Manufacturer Narrative
The manufacture investigation results:: the outer insulation of the shaft has pressure marks.One of these pressure points is pressed through to the metal surface of the shaft, so that a short circuit can occur here.At the distal end, very severe thermal damage can be seen, which may have been caused by too long or high peak voltage.

• Brand Name: COAGULATION AND DISSECTING ELECTRODE
• Common Device Name: MONOPOLAR L-SHAPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17078126
• Report Number: 9610617-2023-00122
• Device Sequence Number: 11297044
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 4048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: ON12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown