FDA Adverse Event Malfunction Summary report: N

SOPHY

MDR report key: 7057619 · Received November 24, 2017

Report

Report Number: 3001587388-2017-17532
Event Type: Malfunction
Date Received: November 24, 2017
Date of Event: November 8, 2017
Report Date: February 8, 2018
Manufacturer: SOPHYSA SA
Product Code: JXG
PMA / PMN Number: K992465
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THE EXPLANTED VALVE WAS RETURNED TO OUR FACILITY AND ANALYSED FOLLOWING OUR QUALITY CONTROL PROCEDURE. THE VALVE WAS NOT RETURNED IN STERILE WATER, AS RECOMMENDED BY OUR IFU : THE ANALYSIS CAN BE MORE COMPLICATED TO PERFORM. VISUAL EXAMINATION: NO MARKS ARE VISIBLE ON THE BODY BUT A COLORLESS LIQUID IS PRESENT IN THE VALVE. A SLIGHT OXYDATION OF THE MAGNETS IS OBSERVED. FUNCTIONAL CONTROL: THE ABILITY OF THE VALVE TO PERFORM AS INTENDED WAS TESTED. CIRCULATION OF AIR AND ALCOHOL IS NOT REMAIN POSSIBLE AND THE BALL IS STUCK ON ITS SEAT; BEFORE AND AFTER CLEANING THE VALVE, THE PROGRAMMATION IS COMPLIANT WITH SPECIFICATIONS. IN CONCLUSION, THE VALVE DOES MEET ITS SPECIFICATIONS., THE DEFECT CAN NOT BE CONFIRMED.

Description of Event or Problem · 0

THE USER REPORTED PRESSURE ADJUSTMENT A DIFFICULTIES, WITH A SPONTANEOUS PRESSURE CHANGE. IN ADDITION, HE REPORTED ADJUSTMENT DIFFICULTIES BETWEEN THE PRESSURE READ USING THE ADJUSTING COMPASS AND PRESSURE READ ON X-RAY IMAGING.

Description of Event or Problem · 1

THE USER REPORTED PRESSURE ADJUSTMENT DIFFICULTIES, WITH A SPONTANEOUS PRESSURE CHANGE. IN ADDITION, HE REPORTED ADJUSTMENT DIFFICULTIES BETWEEN THE PRESSURE READ USING THE ADJUSTING COMPASS AND PRESSURE READ ON X-RAY IMAGING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
836536	SOPHY	SOPHY ADJUSTABLE VALVE	JXG	SOPHYSA SA	SU8	W0016

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention