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

Model Number	WA00014A
Medical Device Problem Codes	Intermittent Continuity (1121); Disconnection (1171)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: (b)(6).Based on the results of the investigation, and since the device was not returned for evaluation, the event was not confirmed, and the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that during a transurethral resection of bladder tumor, electricity did not flow as much as usual, and at some point, began to flow again.When electricity started flowing, no other operations were being performed, only tissue was being scraped.The procedure completed without delay; the irrigation liquid was thought to be saline.Upon observing the bladder interior post-surgery, it was found that tissue in the area where the sheath was had been burned white.Follow up information indicated that treatment for the burn was performed and additionally that the malfunction was caused by disconnection of the cable.Despite multiple attempts to clarify the severity of the burn, the treatment, and the patient outcome, no details were obtained.

• 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, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25754930
• Report Number: 9610773-2026-04808
• Device Sequence Number: 10427184
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: WA00014A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002807798-02/23/2026-00
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400 / SERIAL NO. (B)(6); LOOP ELECTRODE; WA2T43WA OPTICAL TUBE 4MM /SERIAL NO. (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown