MAUDE Adverse Event Report: XOMED MICROFRANCE MFG MICROFRANCE® OTOLOGY INSTRUMENTATION; INSTRUMENT, ENT MANUAL SURGICAL

Model Number MCO13C

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported that the instrument would not grasp.This was discovered pre-operatively.Product analysis discovered that a fragment of the instrument was missing.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The product analysis determined that the base of the fixed jaw is damaged and bent.The pin of the mobile jaw is broken.A fragment is still inside the jaw hole and the other was not returned with the instrument.The pin was probably broken because of a fall or an excessive effort on the forceps, as the deformation of the fixed jaw shows.No material or manufacturing defect has been found.(b)(4).

• Brand Name: MICROFRANCE® OTOLOGY INSTRUMENTATION
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• 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: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 3875236
• MDR Text Key: 20321937
• Report Number: 9680837-2014-00049
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCO13C
• Device Catalogue Number: MCO13C
• Device Lot Number: 131101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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