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

Model Number	27040DB
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that smoke had come out during the intervention and the device got fire.There was a surgical prolongation "delay" because they had to change the resection area per operation." procedure was completed successfully, no medical/ surgical/ diagnostical intervention was required.No adverse consequences reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The product was returned on april 3, 2024.The lot code was incorrect in the intial report and was therefore corrected within this report to yq01 with the manufacturing date november 2019.The investigation of the product was completed on may 7, 2024.Several defects have been found on the product.There is a pressure mark on the top of the appliance.The screws at the rear of the appliance are damaged.It was also found that the lettering on the quick coupling had been taped off and re-blasted, indicating that it had been repaired by a third party.Furthermore, some kind of soiling was found on the rear part, indicating thermal damage.This damage is most likely due to a damp cable that caused a short circuit.This led to overheating and smoke development, which in turn deposited as dirt on the working element.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: RIGID ENDOSCOPE WORKING GUIDE
• 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: 19088626
• Report Number: 9610617-2024-00103
• Device Sequence Number: 7819390
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• 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
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: YQ01
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Patient Sex: Unknown