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

Model Number	26006M
Medical Device Problem Codes	Arcing (2583); Sparking (2595); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2024, the surgical tech stated the unipolar high frequency cord spark and the cord detached from the adapter.However, no injuries were reported to the patient or the surgerical staff.
Additional Manufacturer Narrative
Per investigation from the manufacturing site: the most probable root cause is either mechanical stress damage or a defect because of the end of life of the cable.The cable isolation as well as the copper wire itself were cut.Therefore, no current flow was given.This led to a high contact resistance which was the cause of the sparks, seen by the user.According to similar cases, this failure happens when the product lifetime has exceeded.Because no manufacturing date and no delivery date are known, the actual age of the cable is unknown.According to the picture provided by the customer and the applicable defect, it could be assumed that either mechanical stress has cut the cable or the lifetime has been exceeded, and therefore the material becomes weak.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, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, AL 90245 ; 4242188247
• MDR Report Key: 20054306
• Report Number: 9610617-2024-00250
• Device Sequence Number: 7955919
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 04048551090916
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 26006M
• Device Catalogue Number: 26006M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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