InjuryFHM

GIA PREMIUM

Received May 20, 2020 · Event occurred Apr 1, 2020

Report 2647580-2020-01596 · MDR key 10076615

Device

Generic name

Apparatus, Suturing, Stomach And Intestinal

Manufacturer

Us Surgical Puerto Rico

Model number

030735L

Catalog number

030735L

Product problems

Failure to Form Staple
Failure to Form Staple

Patient

Not reported

No Code Available
No Code Available

Narrative

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING OPEN GASTRECTOMY, WHEN FIRING STOMACH, POOR STAPLE FORMATION WAS OBSERVED. THE STAPLE LINE HAD TO BE OVERSEWN TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE REPORTED EVENT.