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

Model Number	26159BE
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery, an intracavitary flash occurred.The bipolar electrode was stuck inside the hysteroscope sheath.As a result, the patient had a superficial endometrial burn.
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).
Additional Manufacturer Narrative
Please note, that an additional product was added later to this case.The additional information is provided in section d10 the event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was not available for physical investigation.However, the available information has been reviewed.The investigation was completed on 2024-08-08.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.Based on the available information, the evaluation of two of the involved products, the failure description and similar complaints, it can be concluded that the most probable cause is that the laser came into contact with another instrument during use, resulting in a flashover (flash of light).The resulting heat may have caused burns.Internal karl storz reference number: (b)(4).

• Brand Name: BIPOLAR DISSECTION ELECTRODE
• Common Device Name: BIPOLAR 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: 19608433
• Report Number: 9610617-2024-00185
• Device Sequence Number: 15484169
• Product Code: GCJ
• UDI-Device Identifier: 04048551094228
• UDI-Public: 4048551094228
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951986
• 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): 08/09/2024

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: 26159BE
• Device Catalogue Number: 26159BE
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 06/26/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL NUMBER: UF902, SN: (B)(6).; MATERIAL: 26153BI, LOT: RL01.; MATERIAL: 26176LV, LOT: XO01.; MATERIAL: UH400E, SN: (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown