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

Model Number 777000

Device Problems No Device Output (1435); Defective Component (2292)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Evaluation found the reported issue of ¿would not turn on¿ was confirmed.The device was found with faulty psu (power supply unit).Using a reference psu, the unit started up and display showed serial # 0000000.Further inspection found unit missing 2 mounting feet, fan does not work and d socket was missing.In addition, during testing, the unit failed hand switch test rh #9 due to faulty auxiliary board and the output power at pbdes 200w, 300r over limit> 50mv due to faulty plasma blend board.The unit is running an old version software v2.06 and needs to be upgraded to v2.07.The housing has multiple minor scratches can use as is.Review of fault log shows 400 ref 20, two times: front panel: standby button stuck.The usual cause is that the relevant button is held down during power on self test or there is a faulty membrance keypad.600 ref 14, two times: footswitch mode pedal stuck.The usual cause is that the relevant foot pedal is held down by the user or there is a faulty foot pedal.100 ref 10, one time: software execution failure (watchdog reset).The generator software routines were interrupted unexpectedly by a watchdog reset) this can be cause by power¿ brown outs¿ or internal faults.Based on evaluation findings the reported failure was found to be attributed to faulty psu unit.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported the device would not turn on.Power cord was replaced and it is not working.The issue found at preparation for use.Another similar device from the other room was obtained.The intended procedure was completed.There is no patient involvement associated on this reported event.No user injury reported.Device evaluation found faulty psu (power supply unit).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, the cause of the device not powering on was due to a faulty power supply unit.The specific root cause of the power supply unit failure could not be determined at this time.Olympus will continue to monitor field performance 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
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12815854
• MDR Text Key: 282277612
• Report Number: 3003790304-2021-00164
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: POWER CORD