inforMED
MalfunctionFHM

GIA PREMIUM

Received Apr 1, 2019 · Event occurred Mar 11, 2019

Report 2647580-2019-01759 · MDR key 8471687

Device

Generic name

Apparatus, Suturing, Stomach And Intestinal

Model number

030735L

Catalog number

030735L

Lot number

P8G1401X

Product problems

  • Failure to Fire
  • Failure to Fire

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

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 AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, WHILE DIVIDING THE COLON, THE SURGEON COULD NOT FIRE THE DEVICE. THE BLACK PUSHER THUMB COULD NOT BE MOVED AT ALL. AFTER INSPECTION OF THE RELOAD, THEY NOTICED THAT THERE WERE NO STAPLES IN ROWS. THEY USED A NEW RELOAD WITH THE SAME HANDLE, AND EVERYTHING GONE WELL. THERE WAS NO PATIENT INJURY.