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

Model Number MCEN134

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

It was reported that the tip of the instruments broke off during the surgery, and the size of the fragment was ¿huge." there was no reported patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.Concomitant medical products: suction tube mcen769 dia 3.5mm 60deg, lot#130302, manufacture date: march 2013.(b)(4).The product analysis determined that for the suction tube mcen134 110mm malle wormald, ¿the distal part of the tube is broken.No welding or material defect was found.The most probable cause of this breakage is an excessive effort on the instrument during its use.¿ analysis of suction tube mcen769 dia 3.5mm 60deg found ¿the tube is unwelded from the proximal part.The laser welding is not compliant with the manufacturing specifications.¿.

• Brand Name: MICROFRANCE® INSTRUMENT
• 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: 4218091
• MDR Text Key: 4971408
• Report Number: 9680837-2014-00092
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• 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: MCEN134
• Device Catalogue Number: MCEN134
• Device Lot Number: 201206MF2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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