MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMAROLLER"; PLASMA ROLLER

Model Number	WA22738S
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that her olympus hf plasma roller experienced an out of box failure.According to the initial reporter, the distal end of the device broke off inside the patient¿s bladder.Reportedly, the separated portion was successfully removed with no patient harm.Additional details relating to how the procedure was completed and whether the device will be returned have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This supplemental report is being submitted correct the event type from malfunction only to serious injury as well.Corrections made to b1, b2, h1, and h6.This supplemental report is also being submitted to provide the results of the device evaluation and legal manufacturer's final investigation.New information added on fields: d9, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it was likely that the issue was caused by wear and tear.The loop on the distal end of the electrode could wear out during use and might have broken, burned, or melted, especially if the electrode had been used multiple times.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's updated investigation.The device was evaluated by olympus.The loop wire is completely missing, however was returned with the device.Additionally, a microscope was used to inspect the device and found evidence of charred marks on the blue and yellow filters from the distal end side.

• Brand Name: HF-RESECTION ELECTRODE "PLASMAROLLER"
• Common Device Name: PLASMA ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17424507
• Report Number: 9610773-2023-02063
• Device Sequence Number: 5931163
• Product Code: FAS
• UDI-Device Identifier: 14042761085417
• UDI-Public: 14042761085417
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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: WA22738S
• Device Lot Number: 1000044093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 09/02/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/02/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown