ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM
Received May 21, 2009 · Event occurred Apr 17, 2009
Report 3005075853-2009-02976 · MDR key 1392391
Device
Product problems
- Failure to Form Staple
Patient
Not reported
- Surgical procedure, repeated
- Hospitalization required
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE SURGEON, "I DID A LAPAROSCOPIC SIGMOID COLECTOMY ON FRIDAY. I USED A LAPAROSCOPIC GIA TO DIVIDE THE BOWEL DISTALLY, USING ONE RELOAD. I THEN USED AN EEA TO PERFORM THE ANASTOMOSIS. THE STAPLER SEEMED TO FUNCTION APPROPRIATELY, AND I TESTED THE ANASTOMOSIS WITH AIR INSUFFLATION AT THE COMPLETION OF THE CASE. THE ANASTOMOSIS SUBSEQUENTLY LEAKED, AND AT REEXPLORATION, THE ANTERIOR STAPLE LINE WAS DISRUPTED. IN THE COURSE OF TAKING DOWN THE ANASTOMOSIS AT THE SECOND OPERATION, SOME OF THE STAPLES APPEARED TO BE INCOMPLETELY CLOSED. WE SAVED SOME OF THEM TO SHOW YOU. THERE WERE CLEARLY CONSEQUENCES, AS THE PATIENT IS STILL CRITICALLY ILL IN THE ICU WITH SEPSIS, EVEN AFTER REPEAT OPERATION."
Additional Manufacturer Narrative
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.