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

Model Number 777000

Device Problem Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection determined that the unit during start up showed error code 200 ref 54 due to faulty plasma blend board.Using a reference plasma blend board test and during testing the device output voltage were found low due to faulty psu (power supply unit).The device was found running old software version and needs to be upgraded.In addition, multiple minor scratches were found on housing and can use as is.Review of the fault log shows 100 ref 12, one time indicated non volatile memory corrupt or not initialized.Due to no response received and updates from the customer with several follow ups made, the device was returned unrepaired.Customer was notified.Based on evaluation findings reported failure attributed to electronic component failure.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.An investigation has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

It was reported that the device exhibited several faulty codes during preparation for use.There was no patient involvement on this event reported.No user injury reported.No further information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.As a result of the device investigation, olympus is not able to conclusively determine the cause of the board failure, but the age of the device and repeated use are considered contributing factors.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

• 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: 11239970
• MDR Text Key: 257388924
• Report Number: 3003790304-2021-00021
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1