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 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Tac (technical assistance center) support engineer during troubleshooting informed the customer the g400 software needs to be 2.07, if below and connected to the da vinci will get the error.Customer, however was not able to check the software at the time of troubleshooting.Tac noted that to have the software updated will need to send the unit in.If the software is 2.07 will still need to send in it is an internal error.The subject device was received and evaluated.During evaluation and testing, the customer reported error 200 reference 86 was not able to be duplicated, however, during testing, it was found that the output of pb1 100w 100% cut 5r is lower than the limit = 332 mv due to the faulty pkrf board.After using the reference test boards, the unit passed all functional test and 2 hours burn-in test.In addition, the unit is running on old version software v2.06 and needs to be upgraded to v2.07.Review of fault log showed 200 ref 86, five times: indicated rf_det stuck high failure.Rf detect flag high.Based on evaluation findings, the reported issue was not able to be duplicated however, fault log revealed the error reported.In addition, the device was found running an old version software below the sw version v2.07.This likely contributed to customer reported issue.Investigation is ongoing.This report will be supplemented accordingly following investigation completion.

Event Description

Customer reported that in the middle of a therapeutic procedure using the device g400 generator and da vinci robot, are getting an error 200 ref 86 rf_det stuck high failure.Customer stated that it works for about 30 minutes and then stops.Customer has replaced the cord connected to the da vinci and tried another g400 and getting the same error.Device return evaluation found the output of pb1(plasma blend) 100w 100% cut 5r is lower than the limit due to faulty pkrf board.This report is being submitted for low output of pb1 due to faulty pkrf board.

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 board could not be determined at this time.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 21-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Event Description

Customer confirmed the procedure was completed with a similar device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13588575
• MDR Text Key: 288138795
• Report Number: 3003790304-2022-00031
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

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: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/28/2022; 04/28/2022
• Supplement Dates FDA Received: 04/27/2022; 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2012
• 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
• Treatment: DA VINCI ROBOT