MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS; WA22706S

Model Number	WA22706S
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrode probe had a spark present in a working element.The issue was found during a therapeutic transurethral resection (tur) procedure that was completed with a similar device.There were no reports of patient.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation, and correction to field b5.The device was returned to olympus for inspection and the reported failure was not confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: shaft bent at the fork tube section and a bent loop.However, the device was able to work as intended when tested.A definitive root cause for the reported events could not be identified.Based on the results of the investigation, the most likely causes were not established.Olympus will continue to monitor field performance for this device.
Event or Problem Description
There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device manufacturing date.Updated fields : h2, h4.
Event or Problem Description
No additional information provided by the customer.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22706S
• 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 01581 ; 5082077661
• MDR Report Key: 22646810
• Report Number: 3007960282-2025-00114
• Device Sequence Number: 8715743
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: WA22706S
• Device Lot Number: 1000171873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 04/04/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/07/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown