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

Model Number 777000

Device Problems Low Readings (2460); Output below Specifications (3004)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

During a call with tac (technical assistance center) support engineer, customer was provided a sample test of modality pk3 (plasma kinetic mode) testing and the expected readings.The customer was informed that the test results during his output testing for the modality test were correct.The customer tried several other pk3 tests with different loads and confirmed that they were all within the range for the g400 unit.Customer now understood the values he should be reading when performing the output check on the g400 unit.No other issue reported.System is functional.Based on troubleshooting with the customer, the reported issue could be attributed to use error.This report will be supplemented accordingly following investigations.

Event Description

A report of output too low on the generator during an unknown event was reported.The user was performing the output check and when checking, the reading on the pk 3 (plasmakinetic ) mode at 200 w was observed to be low.The user is getting a reading of 173 and felt it was low from the range of 179-215w.There was no patient involvement reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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 complaints for this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR, GYRUS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11713091
• MDR Text Key: 249671473
• Report Number: 3003790304-2021-00072
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1