MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number	WA00014A
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the cable revealed a broken cable and a broken core wire on the fracture surface, as well as melted and burnt marks.Based on the results of the investigation a root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the electrical-only medical device connection cable, reusable had one of the two prongs on the scope side spark and melt.The event occurred during a transurethral resection of bladder tumor (turbt) therapeutic procedure, which was completed using a similar device.There were no reports of patient harm.

• Brand Name: HF-CABLE, BIPOLAR
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24304486
• Report Number: 9610773-2026-00913
• Device Sequence Number: 12090791
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: WA00014A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown