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

Model Number 744000

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that the generator did not fulgurate but would only resect.It was displaying checks for irrigation and electrodes.The event was found during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and device evaluation results.New information added to the following fields: b5, d9, h3, h4, h6 and h10.Correction added in fields: d3, g1 and facility number should be 3011050570 instead of 3003790304 in the mfr.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over twenty (20) years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported the intended procedure was diagnostic.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; brooklyn park MN 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; brooklyn park, MA 01581 ; 5082077661
• MDR Report Key: 18920771
• MDR Text Key: 337859729
• Report Number: 3003790304-2024-00021
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2004
• 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