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

Model Number	27040DB
Medical Device Problem Codes	Energy Output Problem (1431); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, during a bipolar photovaporization of the prostate: black smoke and flame on the connection of the bipolar cable and the resectoscope occurred.No negative effects on the patient were reported.But the surgeon suffered burns.
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).
Additional Manufacturer Narrative
As the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2024-09-19.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 information available, the description of the failure and similar complaints, the problem was most likely caused not by the work element, but by the corresponding cable attached to the handle.Most likely, residual moisture in the cable caused a short circuit, resulting in flames and smoke.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was returned on november 19, 2024.The investigation of the product was completed on 2024-nov-22.The investigation of the returned product confirmed the initial results of the investigation mentioned above.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RIGID ENDOSCOPE WORKING GUIDE
• Common Device Name: WORKING ELEMENT, BIPOLAR
• 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: 19829376
• Report Number: 9610617-2024-00227
• Device Sequence Number: 20688154
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 04048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/17/2024

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: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: RN07
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 11/19/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/24/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown