MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. RAD®; BUR, EAR, NOSE AND THROAT

Model Number 1883519HR

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

Tried putting the microdebrider handpiece into the microdebrider and it did not fit correctly.A new handpiece was opened, and it fit into place easily.The handpiece lawson number is 225142.It is a 90 degree, 11 cm x 3.5 mm ref# (b)(4) microdebrider blade.

• Brand Name: RAD®
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jacksonville FL 32216
• MDR Report Key: 15915052
• MDR Text Key: 304835730
• Report Number: 15915052
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

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 Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: 0225081914
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female