MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TEFLON INSULATED GUARD ON BOVIE TIP; EAR, NOSE, AND THROAT SURGICAL TRAY

Model Number DYNJ59913C

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

Two instances where the insulated guard on the teflon bovie tip in ent pack has come off during case.Some others have been found loose and free from bovie tip in ent and flap packs prior to opening.This is plastic and not x-ray detectable.No harm and manufacturer rep is involved.Reference report #mw5151220.

• Brand Name: TEFLON INSULATED GUARD ON BOVIE TIP
• Type of Device: EAR, NOSE, AND THROAT SURGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 18675542
• MDR Text Key: 335106270
• Report Number: MW5151219
• Device Sequence Number: 1
• Product Code: OGR
• Combination Product (y/n): N
• 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: 02/06/2024

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: DYNJ59913C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male