MalfunctionFHM
PREMIUM MULTIFIRE TA
Received Aug 23, 2017 · Event occurred Mar 30, 2017
Report 2647580-2017-06211 · MDR key 6813988
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Us Surgical Puerto RicoModel number
010315-Catalog number
010315-
Lot number
UNKNOWN
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ACCORDING TO THE REPORTER: OCCURRED DURING A LUNG TRANSPLANT. THE STAPLER JAMMED AFTER ONE USE. THE STAPLER CARTRIDGE WOULD NOT REMOVE FROM THE DEVICE. THE CARTRIDGE WAS NOT ABLE TO BE REMOVED OR LOADED INTO THE HANDLE. TO RESOLVE THE ISSUE, A NEW STAPLER WAS USED. THERE WAS NO PATIENT INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT STATUS IS OKAY.