MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC CONMED OVAL BURR; BUR, EAR, NOSE AND THROAT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

Conmed 4mm oval burr broke inside of conmed shaver handpiece during use.Burr broke off in exterior part of burr housing, not inside patient.Plastic from housing retrieved from sterile field.New burr and handpiece obtained, no significant delay in care.Equipment id is unknown as packages were thrown away.Fda safety report id # (b)(4).

• Brand Name: CONMED OVAL BURR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC
• MDR Report Key: 11108070
• MDR Text Key: 225118910
• Report Number: MW5098625
• Device Sequence Number: 1
• Product Code: EQJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR