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

Model Number	277KB
Medical Device Problem Codes	Material Separation (1562); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a monopolar resectoscope cable burnt out during the procedure.The customer heard a loud band and noticed the cable was severed close to the resectoscope.The customer had to open another resectoscope tray.No patient involvement.No information on length of surgical delay or prolongation of surgery.The procedure was completed without any patient injury or harm reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The following products were returned to the manufacturer for inspection: product a: 277kb - unipolar high-frequency cord, 300 cm.Product b: 27050e - working element.Product c: 011110-10 - electrode, unipolar, angled (not returned).Investigation findings product a - high-frequency cord (277kb) the customer's reported issue was confirmed during the manufacturer's technical inspection.The most probable root cause is aging and wear and tear due to prolonged use.The cable was manufactured in september 2016, and given its age, it is assumed that the product underwent a high number of reuses.Inspection revealed damage consistent with electrical failure: likely internal copper wire breakage, increasing electrical resistance as more strands break, resistance rises, causing higher current stress from the hf generator.This leads to sparking and insulation breakdown, producing loud sounds and visible sparks or flames during use the instructions for use (ifu) clearly highlight: pre-use inspection requirements potential failure modes of the product.Product b - working element (27050e) product b was inspected and found to be functioning properly.No defects contributing to the reported incident were identified.Product c - electrode (011110-10).This item was not returned for investigation and was reportedly discarded by the user.Based on the information available, product c is assessed as not causative in this case.Conclusion the reported issue is attributed to the normal aging and mechanical wear of product a (277kb high-frequency cord).Due to the age and assumed repeated use, the electrical safety of the device could no longer be ensured, leading to the observed malfunction.No manufacturing defects were identified during the investigation.Users should follow the ifu recommendations for regular inspection and timely replacement of reusable devices to prevent similar occurrences.The event is filed under internal karl storz 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, 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: 21426841
• Report Number: 9610617-2025-00262
• Device Sequence Number: 7913917
• Product Code: FJL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 09/04/2026
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/30/2025; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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