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 Type  malfunction  

Event Description

It was reported that four loop instruments broke after their first use.Follow-up information indicates that each device was used in separate cases.The dates of each case are not known.This regulatory report is being submitted for lot 131001.The remaining loops will be submitted on three separate regulatory reports.(b)(4).There was no injury reported as a result of each event.

Manufacturer Narrative

(b)(4).Four devices were returned for repair/evaluation.The product analysis indicates that the loops were broken right after the laser welds.Two of the four fragments were returned.The other two were recovered and were not in contact with the patient.No material or manufacturing defect was found.The cause of the breaks could not be determined.The breaks may be a result of excessive effort during use.Result: stress problem.(b)(4).This device is used for therapeutic purposes.

• 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: 4219588
• MDR Text Key: 21526763
• Report Number: 9680837-2014-00095
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/07/2014

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: 7718
• Device Catalogue Number: 7718
• Device Lot Number: 131001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• 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