MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC EASYDRILL CRANIAL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

Device Problem Failure to Auto Stop (2938)

Patient Problem Contusion (1787)

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Perforator did not stop operating as expected and came in contact with the brain and caused small localized contusion.

• Brand Name: MEDTRONIC EASYDRILL CRANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MEDTRONIC, INC. ; 4620 north beach street; fort worth TX 76137
• MDR Report Key: 11055429
• MDR Text Key: 223408458
• Report Number: MW5098472
• Device Sequence Number: 1
• Product Code: HBF
• 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: 12/17/2020

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 Expiration Date: 11/18/2021
• Device Model Number: DM0010FAA
• Device Lot Number: 1614 / 19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• 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: 37 YR
• Patient Weight: 69