MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	27040EB
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).Cross reference to case (b)(4).
Event or Problem Description
It was reported that the instrument does not work correctly, it does not cut, the working element heats up, the handles of consumables are damaged, adverse consequences user: the doctor suffered a burn from the working element.Currently the doctor no longer has any injuries and is doing.It has already caused harm to a patient harm to patient is covered under medwatch 9610617-2024-00309.
Additional Manufacturer Narrative
Additional information is provided in section b5, d9 and e1.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: since the product is in good condition and not damaged, it is supposed that the application is faulty.Another possible cause is that the sling used became too hot during application and heated the working element.Since no sling was returned, this cannot be investigated further.Since the current flow in a bipolar loop is only through the loop, the statement that the working element has heated up cannot be verified.However, since the article was labeled "vitalmex.," it can be assumed that it was repaired by an external company.Otherwise, the device shows no visible damage and is in good condition.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20191999
• Report Number: 9610617-2024-00310
• Device Sequence Number: 12513198
• Product Code: FAS
• UDI-Device Identifier: 04048551075623
• UDI-Public: 04048551075623
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K221893
• 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): 10/24/2024

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: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: PL12
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 10/11/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/26/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown