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

Model Number 744000

Device Problems Output below Specifications (3004); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

Device was inspected and tested.During testing the output of pk2@ 80wthermionic voltage threshold was found lower than the limit due to faulty socket select board.The current software is v3.03.The housing has multiple minor scratches can use as is.Review of fault log showed error 400 ref 26, four times: generated if a turis electrode is attached and activated without a saline solution being present, or there is an electrode connection fault.400 ref 11, one time: footswitch yellow pedal stuck.The usual cause is that the relevant footpedal is held down during power on self-test or there is a faulty footpedal.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

During an asset return inspection it was found the output of pk2@ 80wthermionic voltage threshold is lower than the limit due to faulty socket select board unit.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, the unit was found to have lower output due to a faulty socket select board.A definitive root cause cannot be identified.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 ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13407124
• MDR Text Key: 294162938
• Report Number: 3003790304-2022-00020
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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