InjuryFHM
GIA 90 PREMIUM STAINLESS STEEL DLU
Received Jun 28, 2007 · Event occurred May 12, 2010
Report 2647580-2010-00594 · MDR key 1743884
Device
Product problems
- Component Missing
- Failure to Fire
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). (B)(4).
Description of Event or Problem
PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: INSTRUMENT WAS FIRED. TISSUE WAS TRANSECTED, BUT NO STAPLES WERE FIRED. IT WAS OBSERVED THAT THERE WERE NO STAPLES IN THE CARTRIDGE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. NO TISSUE DAMAGE OR PT INJURY REPORTED. NO ADD'L BLEEDING AND THE OPERATING TIME WAS NOT EXTENDED OVER 30 MINUTES. NO PT INJURY WAS REPORTED.