MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1882940

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Material Fragmentation (1261)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported ¿that during a case the tip of the inner blade broke off and fell into the patient.They were able to successfully retrieve the fragment.There was no patient injury as a result of this break.They were able to complete the procedure and the patient was not injured; however, the patient did experience added anesthesia time and had to get an x-ray to help locate the piece of the broken blade.¿.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis of the device is expected, but not yet begun.

Manufacturer Narrative

Date of this report: 03/11/2015.Date manufacturer received: 04/14/2015.Product evaluation: analysis found that when viewed under magnification it was observed that the tip of the inner tube had broken off at the proximal edge of the mouth opening.The sample had score marks on the back side of the tip and gouging on the sides of the mouth opening where the inner tube tip caught on the outer tube mouth opening.This indicates excess pressure.Note: [excess: exceeded sufficient pressure required for operation].Instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.(b)(4).

Manufacturer Narrative

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

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• 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: 4656885
• MDR Text Key: 5606663
• Report Number: 3004209178-2015-05917
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 1882940
• Device Catalogue Number: 1882940
• Device Lot Number: H9096804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided; 04/14/2015
• Supplement Dates FDA Received: 04/15/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00016 YR
• Patient Weight: 74