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

Model Number	27040DB
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/10/2024
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).
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.

• 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
• MDR Report Key: 19829323
• Report Number: 2020550-2024-00227
• Device Sequence Number: 20711279
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 04048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024
• Report Date (Section F): 07/25/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• 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