FDA Adverse Event Malfunction Summary report: N

MICROFRANCE® INSTRUMENT

MDR report key: 4090462 · Received September 15, 2014

Report

Report Number: 9680837-2014-00076
Event Type: Malfunction
Date Received: September 15, 2014
Report Date: August 22, 2014
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GCJ
PMA / PMN Number: K080257
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: INSERT CEV625-1 FENESTRATED 310MM, 510K: K993655, LOT# 140408 MFR DATE: APRIL 2014. (B)(4). THE PRODUCT ANALYSIS FOR TUBE CEV649X5 DIA 5MM 310MM DETERMINED THAT THE DISTAL THREADED PART IS BROKEN. THE FRAGMENT WAS RETURNED WITH THE TUBE. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND AND THE THICKNESS OF THE BROKEN PART IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS. THE PRODUCT ANALYSIS FOR INSERT CEV625-1 FENESTRATED 310MM DETERMINED THAT THE INSERT IS SLIGHTLY BENT BUT REMAINS FULLY OPERATIONAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A ¿BROKEN SCREW ON THE TUBE.¿ THERE WAS NO REPORT OF PATIENT IMPACT. THE ANALYSIS CONFIRMED THAT THERE WAS A FRAGMENTED PIECE FROM THE END OF THE DEVICE CLOSEST TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
569757	MICROFRANCE® INSTRUMENT	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	XOMED MICROFRANCE MFG	CEV649X5	140302

Patients

Seq	Age	Sex	Outcome	Treatment
1