FDA Adverse Event Malfunction Summary report: N

CD001, 10MM RETRIEVAL SYSTEM, 10/BX

MDR report key: 4093946 · Received September 16, 2014

Report

Report Number: 2027111-2014-00339
Event Type: Malfunction
Date Received: September 16, 2014
Date of Event: August 19, 2014
Report Date: November 14, 2014
Manufacturer: APPLIED MEDICAL
Product Code: GCJ
PMA / PMN Number: K060051
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: UPON INSPECTION, ENGINEERING CONFIRMED A SMALL TEAR NEAR THE BOTTOM OF THE BAG. THE BAG SHOWED SIGNS OF TENSION, CLEARLY VISIBLE IN THE STRETCHING NEAR THE BURST SITE. PREVIOUS TESTS HAVE SHOWN IDENTICAL STRETCHING AND BREAKING IN RETRIEVAL BAGS WHEN EXCESSIVE FORCE AND MANIPULATION IS USED TO REMOVE SPECIMENS FROM A SMALL INCISION; HOWEVER, FRAGMENTATION OF THE BAG HAS NOT BEEN OBSERVED DURING TESTING. THE INSTRUCTIONS FOR USE STATE, "NOTE: IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." WHEN THE INCISION IS ENLARGED, THE SPECIMEN CAN BE REMOVED WITHOUT INCIDENT. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

Additional Manufacturer Narrative · 1

THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

Description of Event or Problem · 1

REMOVAL OF A GALLBLADDER- "PARTS FROM INZII BAG LEFT INSIDE PATIENT. PIECE OF BAG THAT TORE OFF WAS RETRIEVED FROM PATIENT."PATIENT STATUS: GOOD

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
571556	CD001, 10MM RETRIEVAL SYSTEM, 10/BX	GCJ	GCJ	APPLIED MEDICAL	CD001	1221801

Patients

Seq	Age	Sex	Outcome	Treatment
1