MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMABAND", BAND, MEDIUM, 24 FR., 12°/16°, ESG TURIS; RESECTION ELECTRODES WITH HF CABLE

Model Number	WA22721S
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the electrosurgical generator had insufficient conductivity error code: e006.The issue occurred during reprocessing and there were no reports of patient involvement.It was later reported the procedure was approximately two- three hours and the usual procedure time is 45 minutes.The patient was under general anesthesia and the procedure was completed.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Additional information received: it was reported that the procedure was a therapeutic transurethral resection (tur) vesical and a delay of 2-3 hours occurred.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide an update to fields (b5).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not returned, and the root cause of the suggested event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMABAND", BAND, MEDIUM, 24 FR., 12°/16°, ESG TURIS
• Common Device Name: RESECTION ELECTRODES WITH HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19474048
• Report Number: 9610773-2024-01393
• Device Sequence Number: 4019917
• Product Code: FAS
• UDI-Device Identifier: 14042761085370
• UDI-Public: 14042761085370
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: WA22721S
• Device Lot Number: 1000129881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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: FOOT SWITCH, DOUBLE, FOR, ESG-400.; HF UNIT "ESG-400".
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown