MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number	26775UF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/22/2023
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the patient was burnt in an incident.No further information was provided about the event.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Based on the investigation (2023-07-27) punctual holes in the insulation can be seen in the distal shaft area.Based on the overall traces of use over the length of the shaft, it can be assumed that small cracks/damage were already present before use.The flow of current then caused an electrical flashover at the weakened points, which melted the insulation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL 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: 17109687
• Report Number: 9610617-2023-00126
• Device Sequence Number: 16697465
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 4048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/01/2023

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: WO1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 07/27/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/07/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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