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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Based on the results of the investigation, a definitive root cause for the generator not recognizing the electrode was due to a faulty electrode socket.A device history review revealed no issues that could have caused or contributed to the reported issue.The subject device was manufactured in aug 2021.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device inspection, the generator was not recognizing plasma kinetic electrode due to intermittent failure of the output socket.There were no reports of patient involvement.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18958902
• MDR Text Key: 338352706
• Report Number: 3011050570-2024-00110
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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