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

Model Number	26775UE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
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 while performing hemestasis of the liver, the device had issue in protective sheath which has cause two burn at the pilor/duodena bulb level.
Additional Manufacturer Narrative
The initial report was submitted with an incorrect aware date.New information was provided informing us of the correct aware date of this event in section g3 of the mdr form.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Information was received that the location of the product is unknown and will likely not be returned for evaluation.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
The product was not returned to manufacturer, therefore, the product identification and inspection could not be carried out in our warehouse.The evaluation was based on the customer's pictures and history review.An interruption in insulation is visible approximately 5 cm before the distal end of the electrode, posing a risk of electrical current leakage during use, potentially causing tissue burns.Damage to the insulation could have resulted from mishandling, such as contact with sharp objects during preparation or in the operating theater.The production and test documents show no anomalies.The according instructions for use already state that the item must be checked for damage before use.The event is filed under internal karl storz complaint id: (b)(6).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Common Device Name: COAGULATING AND DISSECTING 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: 18642461
• Report Number: 9610617-2024-00028
• Device Sequence Number: 8063402
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 4048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 04/29/2024

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: 26775UE
• Device Catalogue Number: 26775UE
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 01/03/2024; 03/01/2024; 04/26/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/06/2024; 03/08/2024; 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown