MAUDE Adverse Event Report: GYRUS ACMI, INC. G400 GENERATOR, GYRUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 777000

Device Problem Output Problem (3005)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation confirmed the customer¿s complaint due to a broken pkrf board and a faulty auxiliary board.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the output for the generator is not working.The issue occurred during maintenance.There were no reports of patient harm.

Manufacturer Narrative

Updated: d4 udi number, h4, h6, h10 note: the device was manufactured in january, 2010 - h4 was updated as jan 1, 2010.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.Based on the results of the investigation, the root cause of the reported faulty generator output issue was determined to be due to a faulty circuit board.Olympus will continue to monitor field performance for this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18718253
• MDR Text Key: 336528495
• Report Number: 3011050570-2024-00071
• 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
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 02/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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