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

Model Number 744000

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

As reported, the device not working after plug in the accessories per the nursing staff.The issue found during an unknown event.There was no patient harm or injury reported due to the event.Device evaluation found the output signal failed due to faulty sprf board.

Manufacturer Narrative

Device return inspection did not confirm the customer reported issue of device not working after plug in the accessories¿ issue as the reported compliant was not duplicated however, further inspection found faulty pkrf board.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the device not working after plug in the accessories per the nursing staff.The issue found during an unknown event.There was no patient harm or injury reported due to the event.Device evaluation found the output signal failed due to faulty sprf board.

Manufacturer Narrative

Device return inspection did not confirm the customer reported issue of device not working after plug in the accessories¿ issue as the reported compliant was not duplicated however, further inspection found faulty pkrf board.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2 to add the foreign country.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 16 years since the subject device was manufactured.The unit was received by the service center and it was inspected and tested.The service technician was unable to duplicate the issue the customer reported.The unit was working when accessories were plugged into it.The testing found that the output signal failed due to a faulty "sprf" board.This board failure could attribute to some of the issues that the customer experienced.The unit housing has multiple minor scratches and the display is a little dim.The unit passed all functional tests when used with a test "sprf" board.Olympus will continue to monitor field performance for 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: 13122794
• MDR Text Key: 285966489
• Report Number: 3003790304-2021-00209
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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: 10/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2005
• 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