ADAPTOSIZE
Received Apr 25, 1996 · Event occurred Mar 9, 1994
Report 2126677-1996-00004 · MDR key 33114
Device
Generic name
Metal Film Storage Bin
Manufacturer
Tlk Industries, Inc.Model number
UNKNOWNCatalog number
E1056D
Lot number
UNKNOWN
Product problems
- Design/structure problem
- Product Quality Problem
- Unstable
Patient
UNKNOWN
- Crushing Injury
- Severed digit(s), (finger or toe)
Narrative
Description of Event or Problem
IN THE COURSE OF DEVELOPING ULTRASOUND FILMS IN ACCORDANCE WITH FACILITY INSTRUCTION AND DIRECTION, THE LEAD FILM DRAWER SUDDENLY AND UNEXPECTEDLY SLAMMED ON PLAINTIFF'S HAND. PLAINTIFF SUSTAINED INJURY TO HER LEFT HAND, IN THE FORM OF AN AMPUTATION OF A PORTION OF HER RING FINGER, PARALYSIS, IMPAIRMENT AND DISFIGUREMENT. THE FILM BIN ACCOMMODATES CARTONS OF X-RAY FILM FOR STORAGE IN A DARK ROOM TO PROTECT AGAINST EXPOSURE. THE FILM BIN IS DESIGNED TO BE USED BY X-RAY AND ULTRASOUND TECH IN A HOSP DARK ROOM. THE FILM BIN HOLDS FILM BOXES FOR DEVELOPING X-RAY AND ULTRASOUND FILMS. WHEN THE FILM BIN IS OPENED WITH ITS HANDLE TO THE FULLY OPEN POSITION, IT IS SUPPOSED TO REMAIN OPEN UNTIL CLOSED WITH ITS HANDLE. THE CONSTRUCTION OF THE BIN PREVENTS FILMS FROM BEING EXPOSED. THE FILM BIN WAS DEFECTIVE AND UNSAFE FOR ITS INTENDED PURPOSES AT THE TIME IT LEFT THE CONTROL OF DISTRIBUTOR. THE DESIGN PERMITTED THE FILM BIN TO SUDDENLY AND UNEXPECTEDLY SLAM CLOSED DUE TO THE ABSENCE OF ANY SORT OF CATCH OR STOP TO PROHIBIT THE DRAWER FROM SLAMMING CLOSED. A SAFER ALTERNATIVE DESIGN EXISTED AT THE TIME THE PRODUCT WAS MFG. THE SAFER ALTERNATIVE DESIGN WOULD HAVE PREVENTED OR SIGNIFICANTLY REDUCED THE RISK OF THE PLAINTIFF'S INJURIES, WITHOUT SUBSTANTIALLY IMPAIRING THE PRODUCT'S UTILITY. FURTHERMORE, THE SAFER ALTERNATIVE DESIGN WAS ECONOMICALLY AND TECHNOLOGICALLY FEASIBLE AT THE TIME THE PRODUCT LEFT THE CONTROL OF DISTRIBUTOR APPLICATION OF EXISTING OR REASONABLY ACHIEVABLE SCIENTIFIC KNOWLEDGE. THERE WAS NO WARNING THAT THE DRAWER COULD UNEXPECTEDLY AND SUDDENLY SLAM. (*)