MAUDE Adverse Event Report: GYRUS ACMI, INC. G400 GENERATOR, GYRUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	777000
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the g400 generator's hand switch test failed due to a faulty auxiliary board.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.It is also being supplemented to correct the aware date which should be may 1, 2024 on the initial mdr in section g3, and add new information to sections b5, and h4.The device was returned to olympus for inspection, and it was found that the unit was unable to pass conformance test due to faulty circuit board.In addition, the unit failed lh switch position 9 on hand switch test due to faulty auxilary board.Based on the results of the investigation a definitive root cause is unable to be determined.A review of the service history revew found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the issue occurred during a therapeutic laparoscopic assisted vaginal hysterectomy.The procedure was delayed by ten minutes to allow the device to be switched.The patient was under general anesthesia.

• Brand Name: G400 GENERATOR, GYRUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 19259120
• Report Number: 3011050570-2024-00164
• Device Sequence Number: 6680275
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown