MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS STEALTH MIDAS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number EM200N

Device Problem Overheating of Device (1437)

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

Event Date 04/07/2021

Event Type  malfunction  

Event Description

Neuro coordinator brought a midas rex drill and an attachment to the manager of the central sterile processing department for repair.It was noticed drill was too hot while running.Backup was available, no harm or delay.

• Brand Name: STEALTH MIDAS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 11900671
• MDR Text Key: 253140598
• Report Number: 11900671
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EM200N
• Device Catalogue Number: EM200
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Date Report to Manufacturer: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA