MAUDE Adverse Event Report: GYRUS ACMI, INC GYRUS, PK-SP GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 744000

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated by olympus and it was determined no rv1 output was detected due to a faulty psu board.

Event Description

Upon inspection of the gyrus, pk-sp generator, returned from a user facility for inspection, it was observed that no rv1 output was generated.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

There is more information on the device evaluation.Additional information was received from the customer as well.This supplemental report is being submitted to provide this information.This device is a loaner returned by the customer after the use of the loaner was completed.There was no device malfunction reported with the return.The issue of no output generated was observed when the device was being inspected upon its return.Customer informed that they had no reported events with this device and no reports of error codes associated with it.Customer does not have a record of the last use of this device at the facility.The device history record review would yield no valuable information as this device has been serviced before.A review of the previous shows no abnormalities.This device was returned to the service center as a generic asset return.There were no reported issues when the unit came in.Upon testing and inspection, it was found that the rv1 had no output due to a faulty psu board.The fault log shows error code 400 ref 12 three times: footswitch mode pedal stuck.The usual cause is that the relevant footpedal is held down during power on self test or there is a faulty footpedal.

Manufacturer Narrative

Device was manufacture in october 2005.This supplemental report is being submitted to provide this information.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11260445
• MDR Text Key: 231695090
• Report Number: 3003790304-2021-00023
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 01/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1