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

Model Number 777000

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.During inspection the device serial number showed (b)(4) when turned on.Further inspection found faulty pkrf board causing the current volt limit to be low and cannot be adjusted.The device hand switch lh (left-hand) and rh (right hand) failed testing due to faulty auxiliary board.Plasma blend board was observed to be faulty and unit was found running old software version and needs to be upgraded.Review of fault log showed error code 400 ref 12, one time indicated: footswitch mode pedal stuck.The usual cause is that the relevant foot pedal is held down during power on self-test or there is a faulty foot pedal, error code 400 ref 25, one time indicated: biomed time credit expired.Biomed is notified that time credit is expired.Error code stored in log.The biomed test cable has been used beyond its time limit allocation, error code 100 ref 12, one time indicated: nonvolatile memory corrupt or not initialized.Cpu checks the eeprom can be written to and read from.This error can occur immediately after a software upgrade.The identified parts were replaced, device was repaired and software was upgraded.Once completed, the device was tested and passed required testing and specifications.The investigation is ongoing; therefore, the root cause of the reported failures cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device output power in cut mode were observed to be slightly lower than the range in the users manual.The issue occurred during a preventive maintenance service.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s investigation.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: 11342274
• MDR Text Key: 245759089
• Report Number: 3003790304-2021-00033
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 02/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1