MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® ANGLE-TIP BRONCHIAL BLADE; BUR, EAR, NOSE AND THROAT

Model Number UNKNOWN TRICUT BLADE

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

Patient Problems Tissue Damage (2104); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported to medtronic that a physician was notified by a colleague, that sometime within the past 10 years the following account occurred when a microdebrider was being used with the tricut blade: during a case for ¿laryngeal and tracheal papilloma.This patient suffered a tracheal tear requiring a thoracotomy and a local muscle flap to repair the trachea.¿ the doctor has confirmed that no additional information is available.

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant medical products: 1898200t: microdebrider 1898200t igs m4 510k: k041413 erl.(b)(4).Product evaluation: no analysis results available.Devices will not be returned for evaluation.Method: no testing methods performed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® ANGLE-TIP BRONCHIAL BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3980153
• MDR Text Key: 4632050
• Report Number: 1045254-2014-00171
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2014

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: UNKNOWN TRICUT BLADE
• Device Catalogue Number: UNKNOWN TRICUT BLADE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2014
• Initial Date FDA Received: 08/05/2014
• Supplement Dates Manufacturer Received: 07/12/2014
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention