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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

During a demo asset return inspection, the device was found with low output.A faulty psu (power supply unit) was observed.There is no patient involvement associated on this reported event.No user injury was reported.

Manufacturer Narrative

The subject device was inspected and tested.During inspection it was found the unit missing 1 mounting foot and the bottom case has many deep scratches.During testing, the unit failed hand switch test lh # 9 due to faulty auxiliary board.The output power of pbdes 200w was found too low due to faulty psu (power supply unit) board.The current software is v2.04 and needs to be upgraded to v2.07.The housing has multiple scratches.The fault log shows 200 ref 86 one time, 200 ref 88 one 1 time, 400ref 23 six times and 600 ref 1 two times.Based on evaluation findings the fault found of output too low was found to be due to faulty psu unit.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely the output power of the unit was too low due to a faulty circuit board.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13068101
• MDR Text Key: 286934520
• Report Number: 3003790304-2021-00201
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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