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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection of the unit determined that the core on the pkrf board was broken, causing the pb1 100w cut output to be low.Further testing performed and the unit failed the handswitch test showing error due to faulty auxilliary board.The unit was found running an old software version and needs to be upgraded.Review of data fault log revealed an error 400 ref 10, one time indicated the 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.Error 200 ref 53 showed one time indicated a pk_cut_coag failure [post check].Cpu checks plasma blend relay setting error, error 200 ref 86, showed one time indicated rf_det stuck high failure.Rf detect flag high and error 600 ref 14 showed one time indicated foot switch mode pedal stuck.The usual cause is that relevant foot pedal is held down by the user or there is a faulty foot pedal.Based on evaluation findings the reported failure was due to faulty pkrf board attributed to electronic failure.The investigation is ongoing; therefore, the root cause of the reported issue 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 during an asset return inspection the device was observed with low output due to broken transformer on the pkrf board.There was no patient involvement 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 final investigation.The following sections were updated: g4, g7, h2, h4, h6, and h10.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: 11239737
• MDR Text Key: 255590997
• Report Number: 3003790304-2021-00020
• 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
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1