MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE, LOOP 24 FR., 0.35 WIRE, 12°/16°, STERILE, SINGLE USE, 5; WA22201S

Model Number	WA22201S
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The device evaluation and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
It was reported that loop in the resectoscope were completely burned up after three activations while using a monopolar resectoscope a with generator.The reported issue occurred during an unspecified procedure.There was no report of patient harm or user injury associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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
No additional information received from customer.

• Brand Name: HF-RESECTION ELECTRODE, LOOP 24 FR., 0.35 WIRE, 12°/16°, STERILE, SINGLE USE, 5
• Common Device Name: WA22201S
• Manufacturer (Section D): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• Manufacturer Contact: todd brill ; 801 west park drive; westborough, MA 01582 ; 5082077662
• MDR Report Key: 20801201
• Report Number: 3007960282-2024-10004
• Device Sequence Number: 6764183
• Product Code: FAS
• UDI-Device Identifier: 14042761080061
• UDI-Public: 14042761080061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: WA22201S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/12/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR VLFT10GEN
• Patient Sex: Unknown