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

Model Number 777000

Device Problem No Device Output (1435)

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

Event Date 02/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated at olympus (b)(6).Inspection found no pbdes (plasma blend) output due to faulty pbss (plasma blend socket select) board.The identified faulty unit was replaced and device was repaired.Once completed, the device passed all required testing and specifications.If additional information becomes available this report will be supplemented accordingly following investigations.

Event Description

It was reported that the device has no pb des (plasma blend) output due to faulty pbss (plasma blend socket select) board.The issue occurred during the device maintenance.There was no patient involvement on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A 777000 generator was reported to have no output, this was found during a service event.The root cause of the generators no output was a faulty plasmablend socket select board.The board was then replaced and the unit then passed all inspections and tests.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.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
• MDR Report Key: 11411523
• MDR Text Key: 257389848
• Report Number: 3003790304-2021-00038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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
• Device Catalogue Number: 77000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1