MAUDE Adverse Event Report: MEDTRONIC XOMED, INC MICRODEBRIDER BLADES AND BURS; BUR, EAR, NOSE AND THROAT

Model Number XOM UNK BLADE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

There were two devices used in this procedure, a mdr will be submitted for each.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported where medtronic fusion image guidance system, including, but not limited to the medtronic suction tip and medtronic quadcut debrider were used during a fess surgery.During this surgery it is reported the surgeon broke through the wall of patient's right eye socket (the lamina papyracea) with the medtronic ent guidance system and severed the patient's medial rectus.As a direct and proximate result, the patient sustained severe injuries to his right eye and eye muscles including, but not limited to, severe pain, diplopia (double vision), difficulty with depth perception, nausea, blurring, redness, severe pressure, disorientation with movement, loss of vision over an extended period of time, a foreign body sensation in his eyes, squinting, and limitation of ocular movements.As the further result the patient has undergone revision sinus surgery, and has had to seek treatment for his new and worsening symptoms from additional ent physicians.Also the patient's right eye is permanently positioned 18 degrees to the right.

• Brand Name: MICRODEBRIDER BLADES AND BURS
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 11411632
• MDR Text Key: 234904518
• Report Number: 1045254-2021-00088
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XOM UNK BLADE
• Device Catalogue Number: XOM UNK BLADE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention