MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, ESG TURIS; WA22751S

Model Number	WA22751S
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ball at the tip of the resection electrode device broke off inside the patient.The physician described the event as it "burned off." the event occurred after approximately 20 minutes of use during a therapeutic prostate vaporization.The ball was retrieved intact.The procedure lasted for approximately 70 minutes, with an additional 1-2 minutes in retrieving the broken piece and was completed with a similar device.There were no reports of patient or user harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22751S
• Manufacturer (Section D): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• MDR Report Key: 20632381
• Report Number: 2429304-2024-01001
• Device Sequence Number: 7458424
• Product Code: FAS
• UDI-Device Identifier: 14042761085486
• UDI-Public: 14042761085486
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024
• Report Date (Section F): 11/07/2024

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: WA22751S
• Device Lot Number: 1000132023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR ESG-410, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/07/2024