MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISAO; OTOLOGIC DRILL

Device Problem Overheating of Device (1437)

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

Event Date 01/22/2015

Event Type  malfunction  

Event Description

Visao drill handpiece overheated within approximately the first minute of use.The drill was replaced and the handpiece was tagged.Central sterile was notified and the hand piece picked up by the manufacturer representative for evaluation.

• Brand Name: VISAO
• Type of Device: OTOLOGIC DRILL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint drive north; jacksonville, FL 32216
• MDR Report Key: 4534476
• MDR Text Key: 5543819
• Report Number: 4534476
• Device Sequence Number: 1
• Product Code: DZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/29/2015

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: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2015
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 61