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

Model Number	27040DB
Medical Device Problem Codes	Smoking (1585); Temperature Problem (3022)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/01/2024
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
It was reported that a problem regarding urology bipolar working element 27040db burning and smoking while in use after the case the surgeon has said he has also got sore finger, it was reported there was no harm to the patient.However, due to the mentioned sore finger of the surgeon, this case is deemed reportable.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: RIGID ENDOSCOPE WORKING GUIDE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19995219
• Report Number: 2020550-2024-00292
• Device Sequence Number: 12503533
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 04048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/15/2024
• Report Date (Section F): 08/14/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL: UH801. LOT: NOT AVALIABLE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown