MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MDCONS100

Device Problems Display or Visual Feedback Problem (1184); Energy Output Problem (1431)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned to olympus and a definitive root cause cannot be established.

Event Description

A user facility reported to olympus that the multidebrider power console screen went black but the power remained on.In addition, the hand piece and foot pedal were not working once plugged in even though console was powered up; the issue was characterized by the user facility as intermittent.No patient injury or harm associated with the problem was reported to olympus.The intended procedure is unknown.It is unknown if the procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and device history record (dhr) review.Updates to sections d10 and h6.The suspect device was returned to olympus and evaluated.Visual inspection of the device found no abnormalities in the appearance.The device was powered on to check for functionality and verified all touchscreen buttons responding.When the test handpiece, blades/burr, and a test footswitch were connected, the console would automatically recognize each device and display each icon accordingly.The console was then burn-in tested for six hours and periodically checked with the test handpiece.It was able to generate power output and rotate the test blade window smoothly during the monopolar or bipolar mode inspection.The screen did not go black, and no intermittent issue was observed.The reported complaint was not duplicated.The dhr for the finished device was reviewed and no abnormalities in documentation or process was found.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10092909
• MDR Text Key: 204527645
• Report Number: 3003790304-2020-00013
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1