GIA PREMIUM
Received Mar 28, 2018 · Event occurred Mar 12, 2018
Report 1219930-2018-01749 · MDR key 7379559
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Covidien Lp Llc North HavenModel number
030715Catalog number
030715
Product problems
- Failure to Form Staple
- Failure to Form Staple
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING THE HEMICOLECTOMY SURGERY, THERE WAS AN INCOMPLETE OCCLUSION OF THE SECOND LAYER OF STAPLES DURING THE INTESTINAL ANASTOMOSIS. THE STAPLES STUCK OPEN, SHARP, INTO THE INTESTINAL LUMEN, ABOUT 5 CENTIMETERS IN LENGTH. THE DEVICE HAD BEEN PASSED FOR CHECKING WITH A NEW LOAD. THERE WAS NO PATIENT INJURY.