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

Model Number 744000

Device Problems Electrical /Electronic Property Problem (1198); No Device Output (1435)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received for evaluation and the customers complaint was confirmed.Device evaluation, service performed the superpulse (sp) over voltage test, found error (error message- check irrigation/ electrode) due to faulty pkrf board which caused unit to fail intermittently.Furthermore, inspection found device was running old software v3.02 and needs to be upgraded to v3.03.Unrelated to the reported failure, inspection of the device housing found missing d cover and minor scratches on the housing.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer sent a repair request reported the device exhibited an error message of "check irrigation/ electrode".In addition, preventive maintenance (pm) service request was noted.The reported issue found during an unspecified procedure.There was no patient harm, no user injury reported.Device evaluation found faulty sprf board (circuit board) and caused unit to fail intermittently.This report is being submitted due to the finding of faulty sprf board causing unit to fail intermittently.

Manufacturer Narrative

Updated fields: h4/h6/h10 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.Although it was confirmed the reported error message occurred due to a faulty circuit board, the cause of the circuit board failure could not be specified.Olympus will continue to monitor field performance for this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16633834
• MDR Text Key: 312303026
• Report Number: 3003790304-2023-00141
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2008
• 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