FDA Adverse Event Malfunction Summary report: N

MICROFRANCE® INSTRUMENT

MDR report key: 3948323 · Received July 21, 2014

Report

Report Number: 9680837-2014-00059
Event Type: Malfunction
Date Received: July 21, 2014
Date of Event: June 13, 2014
Report Date: June 26, 2014
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GEI
PMA / PMN Number: K993655
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: TUBE 3PK DIA 5MM 310MM (B)(4); QTY: 1; LOT: 140203; MANUFACTURED: FEBRUARY 2014; 510K: K993655. SCISSORS INSERT 3PK 310MM (B)(4); QTY: 2; LOT: 131201; MANUFACTURED: DECEMBER 2013; 510K: K993655. SCISSORS INSERT 3PK 310MM ((B)(4)); QTY: 3; LOT: 140101; MANUFACTURED: JANUARY 2014; 510K: K99365. (B)(4): IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, A TOTAL OF 8 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): (B)(4) (QUANTITY 1) ¿ THE TUBE IS BROKEN NEAR THE THREAD ON THE PROXIMAL PART OF THE INSTRUMENT. A DIMENSIONAL CHECK DETERMINED THAT IT IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS. NO MANUFACTURING OF MATERIAL DEFECT WAS FOUND. (B)(4) (QUANTITY 2) ¿ ONE OF THE SHEATHS IS BROKEN AT ONE END. THE OTHER SHEATH SHOWS BURN TRACES AT ONE END. (B)(4) (QUANTITY 5) ¿ THE SCISSOR BLADES ARE BLUNT AND NEED SHARPENING. (B)(4)

Description of Event or Problem · 1

TWO 5MM 310MM DIAMETER SHEATHS WERE RETURNED TO MEDTRONIC AND UPON EVALUATION, BURN TRACES WERE OBSERVED AT THE END OF ONE OF THE TWO SHEATHS. THERE WAS NO PATIENT IMPACT. NO OTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
425617	MICROFRANCE® INSTRUMENT	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	XOMED MICROFRANCE MFG	CEV649C5	508269

Patients

Seq	Age	Sex	Outcome	Treatment
1