MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON PREMIUM MF TA* 30-V3 TITANIUM STAPLER; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number 010315

Device Problem Positioning Failure (1158)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

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.

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.

• Type of Device: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6096464
• MDR Text Key: 59754185
• Report Number: 1219930-2016-01182
• Device Sequence Number: 1
• Product Code: FHM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K801589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 010315
• Device Catalogue Number: 010315
• Device Lot Number: N4F0438X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention