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

Model Number 1884380EM

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Quadcut rotatable fusion® blade for ear, nose, and throat (ent) navigation sinus surgery (lot # 0223860601, ref # 1884380em) wasn't working when attached to straight shot hand piece.Quadcut rotatable fusion® blade wouldn't not spin.Clinical staff changed straight shot handpiece first to see if it was the machine or handpiece, but blade still wouldn't spin.Another quadcut rotatable fusion® blade was opened and worked as expected.

• Brand Name: ROTATABLE FUSION®
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 14073373
• MDR Text Key: 289000169
• Report Number: 14073373
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0223860601
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male
• Patient Weight: 50 KG