MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIPOLAR HIGH FREQUENCY CORD, 300 CM

Model Number	26006M
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that procedure on (b)(6) 2024, the unipolar high frequency cord caught fire during the case.The cord melted off at the connecting piece that goes into the electrocautery machine.A saline soaked towel was placed over the very small flame and it was then extinguished.A back-up electrocautery machine and new cord were brought in to complete the case.No user or patient injury was reported.
Additional Manufacturer Narrative
The device will not be returned to us for investigation.However the manufacturing site will be notified of this incident.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19914464
• Report Number: 2020550-2024-00241
• Device Sequence Number: 15353962
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 04048551090916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2024
• Report Date (Section F): 08/05/2024

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
• Device Model Number: 26006M
• Device Catalogue Number: 26006M
• Device Lot Number: P001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2024
• Event Location: Other
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 82 KG