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

Model Number 744000

Device Problems Display or Visual Feedback Problem (1184); Output below Specifications (3004); Output Problem (3005)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

As reported, device showed without code getting 3 way connector or connect cable message.The issue found during an unspecified procedure.There was no patient harm or injury reported due to the event.No user injury was reported.

Manufacturer Narrative

Device evaluation noted unable to duplicate customer reported issue.During testing however, it was found the id select to id3 of right side cannot read due to faulty id board and the output of pk2@ 80wthermionic voltage threshold lower than the limit due to faulty pkrf board.During burn-in, the unit failed due to c72 of sprk board was short.Also found c62 of psu board was discolor and for safety, it was recommended to replace psu board.The current software is v3.02 need to upgrade to v3.03.The housing has some minor scratches.Review of fault log the following error codes were found : the fault log shows 400 ref 12 five times: foot switch mode pedal stuck.The usual cause is that the relevant foot pedal is held down during post or there is a faulty foot pedal.100 ref 10, one time: the generator software routines were interrupted unexpectedly by a watchdog reset.300 ref 21, one time: persistent over voltage or current error.This is very often caused by metallic objects in the vicinity of the electrode tip causing a short or a faulty electrode or cable.Poor operating technique and saline temperature can cause this error.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to inform a correction and updates on event reported.The following sections were updated: b3,b5,g3 g6, h2, h6 and h10.Investigation is ongoing.This report will be supplemented following completion of investigation.

Event Description

Device return evaluation found the id select to id3 of right side cannot read due to faulty id board and the output of pk2@ 80wthermionic voltage threshold lower than the limit due to faulty pkrf board.There is no patient involvement associated on this reported event.This report is being submitted for faulty id board and pkrf board.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, the definitive root cause of the faulty boards could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: 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: 13290600
• MDR Text Key: 294162732
• Report Number: 3003790304-2022-00012
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 12/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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