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 Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Inspection found the device output power of pk3 200w 1k was found too low due to faulty plasma blend board.Using olympus reference test board, the unit passed all functional test and 2 hours burn-in test.Unrelated to the reported issue, it was found the top cover has many scratches and some scratches exposing metal and for safety the top case needs to be replaced.Review of fault log showed error 400 ref 25, ten times indicated biomed time credit expired.Biomed is notified that time credit is expired.Error code stored in log.The biomed test cable has been used beyond its time limit allocation.The operator will have been advised and this error code recorded in the log.Based on evaluation findings, the reported issue was identified to be attributed to a faulty main plasma blend board.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

As reported while doing pm (preventive maintenance), the power outputs were observed to be outside parameter.There was no patient involvement on this reported event.No user injury reported due to the event.Device evaluation found the output power was observed to be too low due to faulty plasma blend board.This report is being submitted for output too low due to faulty plasma blend board.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The customer was doing preventative maintenance on their g400 generator, they experienced some output issues.The power output was outside the outside the normal parameters.The customer returned the generator to the service center for further evaluation.The device was received by the service center.The service technician was able to confirm the same report of abnormal output power.The output power of pk3 200w 1k was too low, this was due to a faulty plasma blend board.After using a test board the unit passed all functional tests.The top cover had multiple scratches, some of these scratches exposed metal.The unit's software was up to date.The dhrs( device history records ) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.No associated (non conformances) ncrs, reported scrap or recorded process deviations relating to the reported failure.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: 12389395
• MDR Text Key: 269297616
• Report Number: 3003790304-2021-00135
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1