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

The returned device was evaluated.Inspection found the customer reported issue was confirmed.Device evaluation found low output.The device output of rv1 150r load was determined to be too low.The unit failed handswitch test at lh (left hand) position #9 due to faulty auxiliary board.The central screw hole of base plate was found damaged and scratches were observed on the keypad.Two missing mounting feet was noted and in addition, the device was observed running an old software version and needs to be upgraded.Unrelated to the reported issue, multiple minor scratches were observed on the housing.Review of fault log revealed error 400 ref one time indicated a foot switch blue pedal stuck.The usual cause is that the relevant foot pedal is held down during post or there is a faulty foot pedal and error 100 ref 10 showed one time indicated a software execution failure (watchdog reset).The generator software routines were interrupted unexpectedly by a watchdog reset.This can be cause by power brown outs or internal faults.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the device exhibited low power output.The issue occurred during device maintenance.There was no patient involvement associated on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A dhr ( device history record ) review has been performed with no issues (ncr¿s (non conformance) or deviations) within the manufacturing process have been indicated which might explain the failure observed.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: 12262515
• MDR Text Key: 264741894
• Report Number: 3003790304-2021-00130
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1