MAUDE Adverse Event Report: GYRUS ACMI, INC GYRUS, PK-SP GENERATOR; GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES

Model Number 744000

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device return was evaluated.Evaluation determined that the unit d socket cover was missing.Device was functionally tested and passed testing, however, during the data log review, an error 400 ref 26 found, occurred one time in the record.This error code generated if a turis electrode is attached and activated without a saline solution.The fault log was cleared and full calibration test was performed.In addition, the identified missing part was replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.

Event Description

It was reported that during the annual asset return inspection the device was found with missing d socket cover.The data log review revealed an error 400 ref 26 error message.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device review of the service history records (shr), please see updated sections: g4, g7, h2, h3, h6 and h10.Review of the previous service records show no abnormalities that could contribute to the reported error.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.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, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 21-jul-2020.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES
• 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: 10466910
• MDR Text Key: 223376717
• Report Number: 3003790304-2020-00075
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2022

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: 08/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 05/19/2022; 11/08/2022
• Supplement Dates FDA Received: 10/28/2020; 06/16/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2003
• 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