MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS; RESECTION ELECTRODES WITH HF CABLE

Model Number	WA22702S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic transurethral resection procedure, the tip of the plasmaloop broke off inside the patient's body and retrieved.The procedure was completed using a back-up device.There was no report of patient harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
• Common Device Name: RESECTION ELECTRODES WITH HF CABLE
• Manufacturer (Section D): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• MDR Report Key: 22331806
• Report Number: 2429304-2025-00189
• Device Sequence Number: 9582730
• Product Code: FAS
• UDI-Device Identifier: 14042761085325
• UDI-Public: 14042761085325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2025
• Report Date (Section F): 06/25/2025

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: WA22702S
• Device Lot Number: 1000178256
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/25/2025