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

Model Number 777000

Device Problem Output below Specifications (3004)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

As reported, device showed e200 ref 53 when powered on.Error was intermittent and becoming more frequent.The issue found at preparation for use.Customer obtained another generator as replacement.There is no patient involvement associated on this reported event.No user injury reported.Device evaluation found output power too low due to faulty psu (power supply unit ) board.This report is being submitted for output too low due to psu failure.

Manufacturer Narrative

Device was received and evaluated.The device when powered on confirmed the customer reported error , as error code 200 ref 53 was observed.The error was due to faulty plasma blend board.Furthermore, the output power of pbdes 200w, 100w and 50w of 20r were observed to be too low due to faulty psu (power supply unit) board.Error was observed during testing on the handswitch test lh (left hand) due to faulty auxiliary board.The unit is running on old version software v2.06 and needs to be upgraded to v2.07.In addition, the following findings were observed on the device: missing 3 mounting feet and d socket cover, key has scratches and some puncture holes need to replace, housing has multiple scratches.Review of fault log, the following errors were observed: the fault log shows 200 ref 53, six times: pk_cut_coag failure [post check].Indicated cpu checks plasma blend setting.200 ref 36, one time: indicated rf relay 2 not operating.400 ref 25, three times: 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.The operator will have been advised and this error code recorded in the log.There is no fault.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 9 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the faulty power supply unit 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
• 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: 13336448
• MDR Text Key: 289462988
• Report Number: 3003790304-2022-00018
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2012
• 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