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

Model Number 744000

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a therapeutic electroscission of urinary tract procedure, the device electric cutting has no output.The intended procedure was completed with another similar device.The device serial number and model used to complete the procedure was not provided.There was no patient impact or harm reported on this event.

Manufacturer Narrative

The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the evaluation completed by olympus china, the inspection result indicated the working element used by the medical staff was found defective.Therefore, it can be concluded there was no issue with the generator.Olympus will continue to monitor complaints for this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GYRUS, PK-SP GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10521167
• MDR Text Key: 207036585
• Report Number: 3003790304-2020-00084
• Device Sequence Number: 1
• Product Code: GEI
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 10/29/2020
• Supplement Dates FDA Received: 10/28/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1