MAUDE Adverse Event Report: XOMED MICROFRANCE MFG MICROFRANCE® INSTRUMENT; FORCEPS, ENT

Model Number MCL19

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

It was reported ¿the tip is bent and there is a small piece broken off.¿ there was no patient impact or injury reported as a result of this event.

Manufacturer Narrative

(b)(4): the device was returned for evaluation.The analyst found the fixed jaw is broken.The fragment has not been returned.A corroded area is visible on the breakage zone.This corrosion is probably anterior to the breakage observed.Considering the age of the instrument (almost 10 years) and the observation of a corroded area anterior to the breakage, the most probable cause is a progressive weakening of the jaw during the life of the instrument (uses / constraints / shocks) which has led to the creation of micro-cracks until the reported breakage.Result ¿ fatigue problem.(b)(4).

• Brand Name: MICROFRANCE® INSTRUMENT
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): XOMED MICROFRANCE MFG; saint-aubin-le-monial; bourbon-l'archambault 3160 ; FR 3160
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 4401933
• MDR Text Key: 15321889
• Report Number: 9680837-2015-00006
• Device Sequence Number: 1
• Product Code: KAE
• 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: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCL19
• Device Catalogue Number: MCL19
• Device Lot Number: 05-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1