MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number XOM UNKNOWN DRILL

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned. A product analysis has not been performed. If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the drill overheated. The product and serial number are unknown. Requests for additional information have been made. There was no reported patient injury or impact.

• Brand Name: XPS® HANDPIECE - UNKNOWN
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 6945859
• MDR Text Key: 90409374
• Report Number: 1045254-2017-00363
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: XOM UNKNOWN DRILL
• Device Catalogue Number: XOM UNKNOWN DRILL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage