MalfunctionFHM
GIA PREMIUM
Received Jul 22, 2019 · Event occurred Jul 4, 2019
Report 2647580-2019-03767 · MDR key 8810333
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Us Surgical Puerto RicoModel number
030735LCatalog number
030735L
Lot number
P8L1191Y
Product problems
- Misfire
- Misfire
Patient
Not reported
- No Information
- No Information
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 OPEN SURGERY, THE TWO RELOADS FIRED PARTIALLY. THE OPERATOR PULLS OUT THE KNOB TWICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.