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

Model Number	26006M
Medical Device Problem Codes	Fire (1245); Flare or Flash (2942)
Health Effect - Clinical Codes	Bowel Burn (1756); Burn(s) (1757)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts were made to obtain more information and to have reported device return for evaluation; however, the reporter has not responded to the requests at the time of this report.If the reported device will be returned or the evaluation is completed, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the unipolar high frequency cord sparked and caught fire during the surgery.While using the electrode to cauterize, the center area of the cord sparked and caught surgical drape and arm cradle foam padding on fire.A small amount of water was used to extinguish the fire.The patient sustained a burn on he inner left forearm and also several spots on the left side of abdomen.
Additional Manufacturer Narrative
Changes made from the initial report: updated section d9 to no.Per investigation by the manufacturing site: it was reported that the unipolar high frequency cord sparked and caught fire during the surgery.While using the electrode to cauterize, the center area of the cord sparked and caught surgical drape and arm cradle foam padding on fire.The patient sustained a burn ont he inner left forearm and also several spots on the left side of abdomen.Most probable root cause: this issue occurs if the cable is used over its intended lifetime.Due to external influences/forces, the electrical resistance increases, and the cable becomes hot or burns.According to the ifu, this issue could happen in given circumstances.Based on the given facts we set the root cause to wearing.This event is filed under internal complaint id (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• 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: 19085265
• Report Number: 9610617-2024-00097
• Device Sequence Number: 12675394
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 04048551090916
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K945380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 26006M
• Device Catalogue Number: 26006M
• Device Lot Number: WZ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Race: White