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

Model Number	277KB
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a resection of the prostate procedure on (b)(6) 2024, the cord sparked when they began to resect.Fibers are coming out of the cord where it connects in to the generator.They were able to complete the procedure using a back-up device without any patient harm.However, the issue caused a delay of the case for about 15 minutes.
Additional Manufacturer Narrative
The device was returned to our us facility on dec-23-2024, and will later 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).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the cable was found cut in close to the bending protection, wires show residues of soot as well as corroded cable ends.Only a few strands show a typical copper color.This means, that only these few strands can provide voltage and current to the instrument.The most probable root cause is the aging of the cable and therefore normal wear and tear due to its age (manufactured in february 2023).The ifu states clearly the exchange of the cable after 3 months when the cable is used 2-3 times a week.It's the customer's responsibility to track take care of the condition of the cable before application.This event is filed under internal complaint (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 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: 21036956
• Report Number: 9610617-2024-00548
• Device Sequence Number: 18050083
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 277KB
• Device Catalogue Number: 277KB
• Device Lot Number: OM01
• Date Returned to Manufacturer: 12/23/2024
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 02/18/2025; 09/04/2026
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/26/2025; 10/01/2026
• 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