MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; WA22707S

Model Number	WA22707S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transurethral resection of the prostate (turp) the subject device broke off inside of patient.The customer reported being unsure where the broken piece is located.The patient is expected to be x-rayed to see if it can be located.No reported harm or injury to the patient at this time.
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 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.
Event or Problem Description
No additional information was received from the customer.
Event or Problem Description
No additional information provided by the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information in h6.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22707S
• 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: 22793029
• Report Number: 3007960282-2025-00133
• Device Sequence Number: 8771303
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

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: WA22707S
• Device Lot Number: TBC1000191862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/12/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 30 DEGREE 4MM TELESCOPE WA2T430A.; INNER SHEATH A22026A.; OUTER SHEATH A22040A.; WORKING ELEMENT WA22367A.
• Patient Sex: Unknown