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

Model Number 744000

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection and testing of the device confirmed the reported issue.The device when tested, generated error code 200 ref 54 due to faulty pkrf board.In addition, the core of the transformer on pkrf board was observed broken.The id and socket select boards were found to be not properly mounted due to broken stands on the pkrf board.Further testing determined that the id band test failed and intermittent due to faulty id board.Using the reference test board, the device was tested and found within specifications and passed the two hour burn in test.Multiple scratches on the housing were observed and dents on the top case were noted.Review of fault log showed 200 ref 54 ten times indicated pk_skt_set failure [post check].Cpu checks socket select relay setting.The identified parts were replaced, fault log was cleared, device was repaired.Once completed the device was tested and passed all required testing and specifications.Based on evaluation findings the reported issue was confirmed.The found failures were attributed to electrical component failure.The investigation is ongoing; therefore, the root cause of the failure cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.

Event Description

It was reported that during preparation for use the device generated error code e200 ref 54.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 device had been serviced by olympus therefore a service history review will replace the dhr (device history record ) review.A review of the previous service report 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: 11342414
• MDR Text Key: 260431961
• Report Number: 3003790304-2021-00034
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 01/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1