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

Model Number 777000

Device Problems Defective Component (2292); 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 reported issue was not able to be duplicated.The unit was tested with reference cables and tested for both port a and b and observed to be functional.The output powers were tested and found to be within specification.Burned in test was performed and passed with no errors observed.Further inspection however, found the loom from vfd (variable frequency drive) to pkrf board was observed to be discolor making poor connection and needs to be replaced.Unrelated to the reported issue, minor scratches on housing unit were observed.Review of fault log found no error.Based on evaluation findings the reported issue was not able to be duplicated however, discolored loom was observed making poor connection.This report will be supplemented accordingly following investigation.

Event Description

It was reported that the device port b is not working.The issue found during preparation for use.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.The device had been previously serviced by olympus therefore a service history review will replace dhr (device history record) review.The review of the previous service shows no abnormalities.Olympus will continue to monitor complaints for 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: 11828377
• MDR Text Key: 257391633
• Report Number: 3003790304-2021-00088
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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: 04/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1