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

Model Number 777000

Device Problem Output below Specifications (3004)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus service representative advised the customer to verify the testing cable wiring per the drawing in the testing procedure.The olympus representative further advised to send the generator in for evaluation and repair if the test equipment was verified to work correctly.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported the g400 generator was reading an output below specifications.The customer reported a reading of 0.3w, below the range in the manual of 69.4w to 96w.The customer reported testing other generators with the test equipment without having any problems.No patient involvement or impact to patient care was reported for this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, an evaluation of the device and a review of the device history record were conducted.The device was returned to olympus for evaluation and repair.The device evaluation found the auxiliary board was not properly mounted due to snaps being broken.The 3 stands on the pkrf board were also broken.The core of the transformer on the pkrf board was damaged.The top and bottom case had dents.During testing error code 200 ref 71 popped up due to a faulty id board.The unit also had minor scratches on the housing.The output power was tested after using test boards and no errors were reported.The fault log for the equipment showed 400 ref 25, ten times: biomed time credit expired.The biomed test cable has been used beyond its time limit allocation.Biomed was notified that time credit is expired and this error code was recorded in the log.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information was provided by the customer on 13apr2021.The reported event was discovered during preventative maintenance.There was no error code received and no error prior to the unit rebooting.The generator was inspected prior to use.The connection between the cord and equipment was secure.There were no concomitant devices and no issues with any other instruments.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the customer on 13apr2021.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11702812
• MDR Text Key: 249062423
• Report Number: 3003790304-2021-00071
• 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,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1