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

Model Number 744000

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

The customer reported to olympus that the device was displaying an check irrigant / electrode message.There was no harm or user injury reported due to the event.

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.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, the customer stated that they were not using a saline solution.The customer called into the technical support line and they continued to test it without saline and were still getting the error.The user manual was then sent to the customer and after they tested the unit with saline the unit tested fine.The customer said they will let the doctor know they must use a saline solution to operate the electrode.The cause of the error was the electrode was attached and activated without saline solution being present.Olympus will continue to monitor the field performance of this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15165580
• MDR Text Key: 303704335
• Report Number: 3003790304-2022-00150
• Device Sequence Number: 1
• Product Code: IYC
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2007
• 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