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 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

The subject asset return device was inspected, tested.During inspection, the core of the transformer on the pkrf board was observed to be broken.The front panel has small dents at bottom right side however, can use as is.The unit passed all functional tests and 2 hours burn-in tests.The current software is v3.03.Review of the fault log showed error 300 ref 21, five times indicated: 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 faulty or cable.Poor operating technique and saline temperature can cause this error.The end-user sees an output shorted message.After three such messages the 300 ref 21 appears in the error log, an error 400 ref 26 showed two times indicated turis electrode is attached and activated without a saline solution being present, or there is an electrode connection fault and error 400 ref 12 showed one time indicated : 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.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

During an asset return inspection for device annual maintenance, the core of the transformer on the pkrf board was found broken.There is no patient involvement 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.The dhr was unable to be reviewed because of the multiple repairs completed on the device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.It has been over 17 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the broken core transformer on the pkrf 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: 12558916
• MDR Text Key: 274580681
• Report Number: 3003790304-2021-00150
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2004
• 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