MAUDE Adverse Event Report: GYRUS ACMI, INC GYRUS, PK-SP GENERATOR

Model Number 744000

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device return was tested and observed that the id band test number 14 failed due to faulty id board.In addition multiple minor scratches were observed on the housing and dents on the top case.Review of data log found an error 200ref 28 indicated a temperature monitor inoperative, check ambient temperature of generator not excessive showed one time on the record.The identified parts were replaced, device was repaired.Once completed the device was tested and passed all required testing and specifications.Based on evaluation findings probable cause of the reported failure can be due to handling and or maintenance issue.

Event Description

It was reported that during an asset return inspection the device failed the id band test.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.This device was returned as a general asset returned.The service center estimated this device.Upon estimation of the device, testing found the id band test #14 failed due to a faulty id board.The unit had multiple minor scratches and the top case has dents.This unit was repaired accordingly.Review of the previous service shows no abnormalities.Olympus will continue to monitor the field performance of this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GYRUS, PK-SP GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11120465
• MDR Text Key: 226266781
• Report Number: 3003790304-2021-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1