MAUDE Adverse Event Report: GYRUS ACMI, INC G400 GENERATOR, GYRUS

Model Number 777000

Device Problems Output below Specifications (3004); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation found output error, testing failed the hand switch test lh (left handpiece) and rh (right handpiece) # 9 due to faulty auxiliary board.The output pbdes 200w testing was observed to be too low due to faulty psu (power supply unit) board.In addition, the unit was found running an old software version and needs to be upgraded.Unrelated to the reported issue, the unit was found missing four (4) mounting feet and several scratches were observed on the front panel and top case.Review of fault log found error 100 ref 18, one time (1) indicated continuous test timing.Cpu checks the timing completed within a certain time frame, 600 ref 14, five times (5) indicated foot switch mode pedal stuck.The usual cause is that the relevant foot pedal is held down by the user or there is a faulty foot pedal.100 ref 10, one time (1) indicated software execution failure.The generator software routines were interrupted unexpectedly by a watchdog reset.This can be caused by power ¿brown outs¿ or internal faults and 400 ref 12, three times (3) indicated footswitch mode pedal stuck.The usual cause is that the relevant foot pedal is held down during power on self-test or there is a faulty foot pedal.Based on evaluation findings, the reported issue was identified to be attributed to a faulty auxiliary board and psu attributed to electronic component failure.This report will be supplemented accordingly following investigations.

Event Description

During an asset return inspection the device failed the handswitch testing, output error due to faulty auxiliary board.There was no patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor the field performance of this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR, GYRUS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11598569
• MDR Text Key: 250777118
• Report Number: 3003790304-2021-00061
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• Combination Product (y/n): N
• PMA/PMN Number: K050550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 777000
• Device Catalogue Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1