PREMIUM MF TA* 30-V3 TITANIUM STAPLER
Received Nov 11, 2016
Report 1219930-2016-01182 · MDR key 6096464
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Covidien, Formerly Us Surgical A DivisonModel number
010315Catalog number
010315
Lot number
N4F0438X
Product problems
- Positioning Failure
- Positioning Failure
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
(B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE PREMIUM MF TA 30-V3 TITANIUM STAPLER AND TWO PREMIUM MF TA 30-V3 TITANIUM DLU . THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS AND AN EVALUATION OF THE RETURNED DEVICE. THE JAWS WERE OPEN. THE SULUS WERE FULLY FIRED; ONE SULU HAD TWO MALFORMED STAPLE. THE SULUS WERE RELOADED WITH STAPLES. THE INSTRUMENT AND SULUS WERE FIRED OVER TEST MEDIA WITH ACCEPTABLE STAPLE FORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
ACCORDING TO THE REPORTER: DURING A THORACIC PROCEDURE, THE DOCTOR ATTEMPTED TO FIRE THE DEVICE ON 2 OCCASIONS RESULTING IN BLEEDING. STAPLER DEPLOYMENT WAS INCOMPLETE, RESULTING IN ONLY PARTIAL LIGATION OF THE PULMONARY VEIN. THE DOCTOR SUBSEQUENTLY LIGATED THE REMAINDER OF THE PULMONARY VEIN WITH PROLENE SUTURE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION AFTER SURGERY.