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.The device would not show the output watts due to the con3 (connector 3) and con4 (connector 4) of the device is in opposite position.The device was found with missing d socket cover.The connector was then placed in right position and the output powers became stable and within specifications.The device underwent two hour burn-in test to see if the unit would malfunction or generate any error codes however, the unit passed with no problems noted.The device was found running an old software version and needs to be upgraded.The housing has multiple minor scratches and found punctured hole in the keypad membrane.Review of error fault log showed error 400 ref 26, eight times indicated that the ituris electrode is attached and activated without a saline solution being present, or there is an electrode connection fault.400 ref 19, showed one time indicated the mode button stuck.The usual cause is that the relevant button is held down during power on self test or there is a faulty membrane keypad.The identified parts were replaced, device was repaired, software was upgraded.Once completed, the device was tested and passed required testing and specification's.Based on evaluation findings the reported issue was due to the device connectors in an opposite position.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during maintenance the device output was observed to be not working.Device was tested with different footswitch and device would not show the output watts.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.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.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 23-dec-2020.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, two inner connectors were in the opposition position, creating the issue.Once the connectors were appropriately placed, the device passed all functional tests.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
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 11243933
• MDR Text Key: 260432092
• Report Number: 3003790304-2021-00022
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2007
• 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
• Treatment: FOOTSWITCH