FDA Adverse Event Malfunction Summary report: N

VERSAJET II EXACT 45DEG X 14MM

MDR report key: 3771233 · Received April 24, 2014

Report

Report Number: 3006760724-2014-00317
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: April 17, 2013
Report Date: April 24, 2014
Manufacturer: SMITH & NEPHEW WOUND MANAGEMENT
Product Code: FQH
PMA / PMN Number: K991383
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED COMPLAINT WAS DEEMED CONFIRMED UPON REVIEW OF THE PHOTOGRAPHS SUBMITTED WITH THE REPORT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION SO A DEFINITIVE ROOT CAUSE FOR THE ISSUE COULD NOT BE IDENTIFIED. HOWEVER, PREVIOUS INVESTIGATIONS OF THE SIMILAR FAILURE MODE ¿HIGH PRESSURE BURST¿ FOR THE VERSAJET I HANDPIECES HAVE DETERMINED THE MOST PROBABLE CAUSE TO BE CRIMPING ISSUES DURING ASSEMBLY THAT LEAD TO FLUID OCCLUSION IN THE HIGH PRESSURE HOSE, LIKELY CLOSE TO HANDSET¿S CUTTING WINDOW. THE MANUFACTURER REVIEWED THE DHR FOR THE REPORTED LOT NUMBER 30312KY AND FOUND ALL REQUIREMENTS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AT THIS TIME, THE ISSUE APPEARS TO BE AN ISOLATED INCIDENT AND NO CORRECTIVE ACTION IS WARRANTED. FUTURE PRODUCT COMPLAINTS WILL CONTINUE TO BE TRACKED AND TRENDED TO DETECT ANY RECURRING ISSUES AND IF NEEDED, ADDITIONAL CORRECTIVE ACTION(S) WILL BE INITIATED AT THAT TIME. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE RENASYS GO RENTAL DEVICE.

Description of Event or Problem · 1

PER CUSTOMER YELLOWISH BROWN CORD EXPLODED WHILE DEVICE WAS IN USE ON A PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249746	VERSAJET II EXACT 45DEG X 14MM	LAVAGE, JET	FQH	SMITH & NEPHEW WOUND MANAGEMENT	66800041	30312KY

Patients

Seq	Age	Sex	Outcome	Treatment
1