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

Model Number 777000

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection found the unit failed the hand switch left and right (lh and rh) handpiece test due to faulty (aux) auxiliary board.The output powers however was noted to be within specifications, was placed in a two hour burn in test.The unit passed the burn in test with no errors observed.Review of fault log showed 400 ref 25 three 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 and 100 ref 12 one (1) time indicated nonvolatile memory corrupt or not initialized.Cpu checks eeprom can be written to and read from.This error can occur immediately after a software upgrade.The identified parts were replaced, device was repaired.Once completed , the device was tested and passed required testing and specifications.Based on evaluation findings the failure found was due to faulty auxiliary board attributed to electronic component failure.This report will be supplemented accordingly following investigations.

Event Description

During an asset return planned maintenance inspection the device failed the hand switch test due to faulty (aux) auxilliary board.There was no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11486289
• MDR Text Key: 245327306
• Report Number: 3003790304-2021-00047
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1