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

Model Number MCO13C

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that an analysis was requested for ¿two instruments that broke quickly after their first uses".The analysis showed that the break created fragments.There was no reported patient impact.

Manufacturer Narrative

Concomitant products: knife mcl59 bayonet monopolar freche, 510k: k993655, lot# 140903, mfr date: september 2014.(b)(4).The product analysis for forceps mco13c alligator 3x0.6mm hartman found that ¿one of the pins of the active part is broken.There is no sign of manufacturing or material defect.The fragments of the pins are still on the instrument and so there is no risk for the patient.The most probable cause of this breakage is an impact or excessive force during the uses or the reprocessing of the instrument.¿ the product analysis for knife mcl59 bayonet monopolar freche, found that ¿the active part is broken and missing.However, the event is most likely to have occurred during the reprocessing.Moreover, the fragment is 25mm long and could not have been left unnoticed.No manufacturing or material defect was found.¿.

• 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: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4644048
• MDR Text Key: 5752313
• Report Number: 9680837-2015-00028
• Device Sequence Number: 1
• Product Code: KAE
• 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,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• 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: 150105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Date Device Manufactured: 01/01/2015
• 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