MAUDE Adverse Event Report: MEDTRONIC XOMED INC. DISSECTOR 3722071 CRABTREE LARGE 90DEG; INSTRUMENT, ENT MANUAL SURGICAL

Model Number 3722071

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

The device was returned for evaluation, and it was noted that the tip of the instrument most proximal to the patient was broken off.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The product analysis determined, ¿received one sample with etching on the instrument which listed the part number as 3722071.Since the original product box/pouch or label was not returned, it could not be confirmed if the returned sample was from the reported complaint lot as recorded in the complaint file.The condition of the device showed customer use based on the damage noticed.The returned instrument tip was found to be broken likely due to customer handling/use of the instrument.Therefore it could not be confirmed if the tip was actually at a 45 degree angle as alleged by the customer.¿ results: fracture problem.

• Brand Name: DISSECTOR 3722071 CRABTREE LARGE 90DEG
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 3773526
• MDR Text Key: 19295577
• Report Number: 1045254-2014-00090
• Device Sequence Number: 1
• Product Code: LRC
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3722071
• Device Catalogue Number: 3722071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1