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

Model Number MCL19

Device Problem Break (1069)

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

Event Date 06/27/2014

Event Type  malfunction  

Event Description

It was reported that a tip of the forceps broke off.Repair of the device was requested.There was no injury reported as a result of this event.

Manufacturer Narrative

(b)(4).The fixed jaw is broken.The fragment was not returned by the client.No material or manufacturing defect has been found.The most probable cause of this breakage is a shock or an excessive effort during use or reprocessing of the instrument.(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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 3956066
• MDR Text Key: 4623332
• Report Number: 9680837-2014-00060
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• 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: 200812MF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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