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

Model Number 27040DB

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 339928072
• Report Number: 9610617-2024-00103
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1