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

Model Number	26006M
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Flare or Flash (2942)
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).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: result of investigation: the cable 26006m, lot po01 was reported to catch fire during use close to the piece that go to the electrocautery machine.Because no product was returned and no pictures were provided by the customer, the investigation is based on similar cases and the experience of the investigator.It is assumed, that the cable has a break of the copper wire inside the insulation which leads to high resistance and therefore the insulation break of and the fire occurred.Most probable root cause: mechanical damage due to end of life of the cable.It is assumed, that the cable has a break of the copper wire insi de the insulation which leads to high resistance and therefore the insulation break of and the fire occurred.The ifu calls out a replacement of the cable after 3 months (by frequent use 2 -3 times a week).According to the manufacturing date of march 2021, it could be assumed that the cable has reached its end of life.Therefore, the defect can be rated as user error, because the user is responsible to check the cables lifetime.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
• 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 ; 4242188247
• MDR Report Key: 19914465
• Report Number: 9610617-2024-00241
• Device Sequence Number: 7602183
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 04048551090916
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 82 KG