FDA Adverse Event Malfunction Summary report: N

CODMAN CLASSIC PLUS

MDR report key: 2439745 · Received January 31, 2012

Report

Report Number
2439745
Event Type
Malfunction
Date Received
January 31, 2012
Date of Event
December 16, 2011
Report Date
January 31, 2012
Manufacturer
CODMAN
Product Code
GDF
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT HAVING AORTIC VALVE REPLACEMENT. A NEEDLE DRIVER WAS BEING USED TO AID SUTURING OF THE VALVE. THE VALVE WAS PLACED UNEVENTFULLY. PT TRANSFERRED TO ICU POST-OP. ON POSTOP DAY 4, AFTER ALL OTHER LINES AND DRAINS WERE REMOVED, SCANS DEMONSTRATED THE PRESENCE OF A SMALL METALLIC OBJECT ABUTTING THE HEART. THE PT RETURNED TO THE OR AND A 1.4CM METALLIC OBJECT WAS RETRIEVED.SUBSEQUENT EXAMINATION OF THE OBJECT CONFIRMED THAT IT WAS A TREAD OF A NEEDLE DRIVER.THE TREAD OF THE NEEDLE DRIVER IS WELDED/SOLDERED ON THE TIP OF THE NEEDLE DRIVER. THIS FRACTURED DURING THE PLACEMENT OF THE VALVE. IT IS BELIEVED IT WAS THE LAST SUTURE PLACED BY THE SURGEON AS THE NEEDLE DRIVER WOULD NOT HAVE FUNCTIONED IF IT WERE REUSED DURING THIS CASE. NOTE THE NEEDLE DRIVER IS REUSED UNTIL THE SUTURING IS COMPLETE OR A DIFFERENT SIZE NEEDLE IS REQUIRED. ONCE A CASE IS COMPLETED, THE OR KIT WHICH CONTAINS THE NEEDLE DRIVER IS RETURNED THE OR STERILIZATION DEPT FOR CLEANING AND THE KIT IS MADE READY FOR THE NEXT CASE.THE NEEDLE DRIVER SUPPLY FOR THE HOSPITAL WAS SEARCHED. A NEEDLE DRIVER WITH A MISSING TREAD WAS FOUND. NOTE, THERE ARE SEVERAL HUNDREDS OF NEEDLE DRIVERS SPREAD OUT OVER MANY HUNDREDS OF OR KITS FOR OUR HOSPITAL. ALSO, EACH OR KIT IS SENT OUT TO A RECONDITIONING COMPANY TO INSPECT ALL KIT CONTENTS FOR INSPECTION, REPAIR AND REFURBISHMENT OF THE SURGICAL INSTRUMENTS. THE KIT WAS RECONDITIONED IN JULY 2011 BY THE REFURBISHING COMPANY. STILL, WE BELIEVE THE NEEDLE DRIVER FOUND WAS THE OFFENDING INSTRUMENT. THE TREAD WAS INSPECTED AND APPEARED TO BE NEW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CODMAN CLASSIC PLUS NEEDLE DRIVER GDF CODMAN 36-2025 *

Patients

Seq Age Sex Outcome Treatment
1 70 YR