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
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-01001.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 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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on final investigation.Updated fields: d9, h3, h4, h6.The device that was returned was only the ball tip and the electrode itself was missing/not returned.The device underwent a visual inspection and confirmed the reported issue that the roller ball tip was detached/broken off.The electrode sheath was missing.A microscope was used to inspect and found charred marks at the breakage of the detached roller ball tip.Based on the results of the investigation, olympus was not able to determine a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
No additional information received from the customer.

• 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
• 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 01582 ; 5082077662
• MDR Report Key: 20635252
• Report Number: 3007960282-2024-10001
• Device Sequence Number: 18000207
• Product Code: FAS
• UDI-Device Identifier: 14042761085486
• UDI-Public: 14042761085486
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/03/2025

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: WA22751S
• Device Lot Number: 1000132023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: GENERATOR ESG-410, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown