MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. FUSION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 1884006EM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

During a left functional endoscopic sinus surgery, the tip of the medtronic fusion rotatable blade rad 40 came loose while in use causing it to be inoperable.

• Brand Name: FUSION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 12575964
• MDR Text Key: 274748319
• Report Number: 12575964
• Device Sequence Number: 1
• Product Code: HAW
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884006EM
• Device Lot Number: 0220804521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 80