MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XOM UNKNOWN BLADE

Model Number UNKNOWN BLADE

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the ¿blades break and stop up too much.¿ there was no reported patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis results are not available; device was not 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: XOM UNKNOWN BLADE
• 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: 4394092
• MDR Text Key: 5303845
• Report Number: 1045254-2015-00007
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BLADE
• Device Catalogue Number: UNKNOWN BLADE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: 12/12/2014
• 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