MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS, PLASMA SECT UROLOGY

Model Number	714520
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	08/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the during a transurethral resection of bladder tumor surgery, the loop of the subject device came off into the bladder and was retrieved with forceps.The procedure was completed with a similar device with a 10-minute delay.The device was inspected prior to use, and it was noted to be intact.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was not returned to olympus for a physical evaluation.Therefore, based on the results of the investigation, the root cause of the reported adverse event could not be established.This supplemental report includes a correction to d2a and d8 from the initial medwatch.Also, an update has been made to d9.Olympus will continue to monitor field performance for this device.

• Brand Name: GYRUS, PLASMA SECT UROLOGY
• Common Device Name: GYRUS, PLASMA SECT UROLOGY
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20346432
• Report Number: 3011050570-2024-00400
• Device Sequence Number: 8000187
• Product Code: FJL
• UDI-Device Identifier: 00821925039575
• UDI-Public: 00821925039575
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K001270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 714520
• Device Lot Number: U2311077
• Was Device Available for Evaluation?: No
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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