MalfunctionFHM
AUTOSUTURE
Received Aug 31, 1994 · Event occurred Feb 4, 1994
Report 18988 · MDR key 18988
Device
Generic name
Disposable Stapler
Manufacturer
Us Surgical CorpModel number
GIA-50 PREMIUMCatalog number
030424
Lot number
UNKNOWN
Patient
27 *
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STAPLER DEVICE FAILED TO FIRE STAPLES INTO THE BOWEL. NO PATIENT INJURY IS KNOWN. THE DEVICE AND PACKAGING WAS NOT SAVED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.