MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, LONG, STERILE, SINGLE US; WA22538C

Model Number	WA22538C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the resection electrode the tip, ball of the snare was detached from the snare and ended up in the bladder.Now a foreign body was present in the patient, it was then recovered.The issue was found during an unknown procedure.There were no reports of patient injury or harm.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, LONG, STERILE, SINGLE US
• Common Device Name: WA22538C
• 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: 24901585
• Report Number: 3007960282-2026-00073
• Device Sequence Number: 8938418
• Product Code: FAS
• UDI-Device Identifier: 14042761073964
• UDI-Public: 14042761073964
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100275 / K
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22538C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown