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

Model Number 744000

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

The customer reported that a gyrus, pk-sp generator had an error message ¿check irrigant/electrode¿ displayed.The event occurred during preparation for use and was completed with a similar device.There was no patient harm associated with the event.

Manufacturer Narrative

The device is pending evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation (check irrigant/electrode error message) was confirmed due to a faulty board.In addition, there were minor scratches on the housing and front panel, and the software needs to be upgraded.

Event Description

The event occurred at the beginning of the therapeutic procedure (transurethral resection of bladder tumor- turbt) when starting the machine.There was a reported delay.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history records were performed previously and found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to a faulty circuit board.Olympus will continue to monitor field performance for this device.

• 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: 17643857
• MDR Text Key: 322200777
• Report Number: 3011050570-2023-00127
• 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,Followup
• Report Date: 10/17/2023

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
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/08/2023; 10/13/2023
• Supplement Dates FDA Received: 09/13/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2010
• 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