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 01/03/2022

Event Type  malfunction  

Event Description

As reported, the unit just turns on and gets red light.It does not work at all.The issue found at receipt inspection.There is no patient involvement associated on this reported event.No user injury reported.Device evaluation found the core of the transformer on pkrf board was broken.This report is being submitted for faulty pkrf board unit.

Manufacturer Narrative

The device inspection found the customer reported issue of ¿the unit just turns on and gets a red light.It doesn't work at all" was confirmed.The issue was due to the connector con5 of psu (power supply unit) board was disconnected.This connector is very hard to disconnect by itself.Once the connector con5 reconnected, using the test reference pkrf board, the unit power up and passed the functional tests and 2 hours burn-in test.The current software is v3.03.Furthermore, during inspection, the core of the transformer on pkrf board and one (1) stand of pkrf board were found broken.Big dent was observed on the device.Review of fault log showed no errors.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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the unit would not power on normally as there was a connector loose on the circuit (psu) board, the core transformer of the circuit (pkrf) board was broken, 1 strand of the pkrf was broken as well.This damage was the likely cause of the issue.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: 13419700
• MDR Text Key: 290002498
• Report Number: 3003790304-2022-00021
• 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: 01/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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