T-REX BIOPSY FORCEPS
Received Jun 27, 2006 · Event occurred May 31, 2006
Report 6000130-2006-00158 · MDR key 734375
Device
Generic name
Biopsy Forceps
Manufacturer
Boston ScientificModel number
NACatalog number
H749234670010
Lot number
8444638
Product problems
- Difficult to Remove
- Replace
- Wire(s), breakage of
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE, FORCEPS REMOVAL DIFFICULTY OCCURRED. THE T-REX BIOPSY FORCEPS WIRE BROKE, LEAVING THE JAWS IN AN OPEN POSITION, MAKING IT "IMPOSSIBLE" TO REMOVE THE DEVICE FROM THE PATIENT. WITH THE USE OF A HEMOSTAT, THE PHYSICIAN WAS ABLE TO GRAB THE WIRES, CLOSE THE JAWS, AND REMOVE THE T-REX BIOPSY FORCEPS FROM THE PATIENT. CURRENT PATIENT STATUS IS REPORTED AS "OKAY". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER T-REX BIOPSY FORCEPS.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.