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

Model Number	26006M
Medical Device Problem Codes	Sparking (2595); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown at this time if the device will be returned for investigation.Should 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, the unipolar high frequency cord popped and sparked.No injurt was noted to the physician or the patient.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: 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.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 inside the insulation which leads to high resistance and therefore the insulation breaks off and the sparks 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 november 2019, it could be concluded 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: Resectoscope
• 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, CA 90245 ; 4242188247
• MDR Report Key: 20246919
• Report Number: 9610617-2024-00254
• Device Sequence Number: 15303161
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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
• Device Lot Number: YQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 09/04/2026
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/25/2024; 10/01/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown