MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE

Model Number MDCONS100

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

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 an unspecified procedure, the device handpiece was not recognized.The intended procedure was completed using another multi-debrider.There were no further details provided regarding the event.There was no patient harm reported, no user injury reported.This complaint is related to patient identifier (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.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.The device return was evaluated.The unit was tested using a test handpiece and passed all functional tests.Minor scratches on the housing was noted.The customer reported failure of 'handpiece not recognized' could not be duplicated.Complaint was not confirmed.Olympus will continue to monitor complaints for this device.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Type of Device: MULTIDEBRIDER POWER CONSOLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10705080
• MDR Text Key: 212327160
• Report Number: 1037007-2020-00063
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDCONS100
• Device Lot Number: RWK IH879067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1