MAUDE Adverse Event Report: XOMED MICROFRANCE MFG MICROFRANCE® INSTRUMENT; LOOP, WIRE

Model Number 7718

Device Problem Material Fragmentation (1261)

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

Event Date 03/17/2015

Event Type  malfunction  

Event Description

It was reported that the instrument broke after a few uses.Requests for additional information have been made with no response received.There was no injury reported as a result of this event.

Manufacturer Narrative

No known impact or consequence to patient ; material fragmentation.The device has not been returned.Therefore, an analysis cannot be performed.This device is used for therapeutic purposes.

Manufacturer Narrative

Correction.Conclusion: device not returned.

Manufacturer Narrative

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

• Brand Name: MICROFRANCE® INSTRUMENT
• Type of Device: LOOP, WIRE
• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 4673995
• MDR Text Key: 5732023
• Report Number: 9680837-2015-00031
• Device Sequence Number: 1
• Product Code: JYQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2015

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: 7718
• Device Catalogue Number: 7718
• Device Lot Number: 130902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided; 06/15/2015
• Supplement Dates FDA Received: 06/15/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2013
• 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