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

Model Number 744000

Device Problem Defective Component (2292)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

During an asset return inspection for sw update, the core of the transformer on pkrf board was observed to be broken (faulty electrode).There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

The unit was inspected, tested.During inspection it was found the core of the transformer on pkrf board broken.The unit passed functional tests and 2 hours burn-in tests.The current software is v2.24 needs upgrade to v 3.03.The housing has multiple minor scratches.Review of fault log found no error.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

The unit was inspected, tested.During inspection it was found the core of the transformer on pkrf board broken.The unit passed functional tests and 2 hours burn-in tests.The current software is v2.24 needs upgrade to v 3.03.The housing has multiple minor scratches.Review of fault log found no error.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

During an asset return inspection for sw update, the core of the transformer on pkrf board was observed to be broken (faulty electrode).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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the broken printed circuit board could not be determined at this time.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 ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12839817
• MDR Text Key: 285966026
• Report Number: 3003790304-2021-00166
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 10/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2007
• 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