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

Model Number 744000

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported issue of pulsating was not able to be duplicated however, during output testing the output power was observed to be low due to faulty circuit board (psu board) found.The device was then tested using the reference test boards and once replaced, testing was performed for output test and burned in test.The device did not generate any error code and passed the burned in test.The unit was running an old software version and needs to be upgraded.Although the reported failure was not duplicated, review of data log revealed an error 400 ref 26 showed 3 times.This error indicated that a turis electrode is attached and activated without a saline solution being present, or there is an electrode connection fault indicated.Error 400 ref 12 (foot switch mode pedal stuck) showed two times on the log, indicated that the relevant foot pedal is held down during post or there is a faulty foot pedal indicated.And 300 ref 21,error message showed in the log one time (persistent over voltage or current error) indicated that this is very often caused by metallic objects in the vicinity of the electrode tip causing a short or faulty cable.Poor operating technique and saline temperature can cause this error.The end-user sees an output shorted message.The device was placed for repair.Based on evaluation findings, the reported issue was not able to be duplicated however, fault errors were observed on the unit¿s data log.Although the reported failure was not able to be duplicated during the device inspection and physical testing, the reported errors, fault found on the data log likely attributed to the reported phenomenon.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that in the middle of a therapeutic prostatectomy procedure, the device was found pulsating when trying to cut.No alarms or alert tones were noted, the device was inspected prior to use and no abnormalities observed.There was an approximately 10 minute delay with the patient under general anesthesia.The intended procedure was completed with the same device and no other devices were involved in the event.There was no patient harm or injury reported, bleeding was reported to be normal.No unintended tissue was burnt.No medical or surgical intervention was required due to the reported phenomenon.The patient current condition is unknown.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Please see updated sections: d4,g4, g7, h2, h6 and h10.The customer reported that the unit was pulsing when trying to cut.This unit was returned to the service center for estimation.The service technician was unable to duplicate the customer's issue.The technician found the unit had lower output due to a faulty psu board.The unit sustained error codes 400 ref 26, 400 ref 12 and 300 ref 21.The unit had multiple scratches on the body.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.There are no issues with the manufacturing process have been indicated which might explain the failures observed.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it is likely the phenomenon was caused by a faulty circuit board.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 ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 10971711
• MDR Text Key: 241743033
• Report Number: 3003790304-2020-00136
• Device Sequence Number: 1
• Product Code: GEI
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• 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
• Patient Sex: Male
• Patient Race: White