TA PREMIUM
Received Sep 26, 2017 · Event occurred Aug 30, 2017
Report 1219930-2017-07389 · MDR key 6893267
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Covidien Lp Llc North HavenModel number
010470Catalog number
010470
Product problems
- Failure to Fire
- Failure to Fire
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A SUB TOTAL GASTRECTOMY PROCEDURE, THE SURGEON CLAMPED THE TISSUE AND STARTED TO SQUEEZE THE HANDLE, HOWEVER COULD NOT FIRE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURING. THE STATUS OF THE PATIENT IS NO PROBLEM.