MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL ENDO GIA UNIVERSAL 12MM SINGLE USE INST; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number 030449

Device Problems Crack (1135); Failure to Form Staple (2579); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Procedure type: lobectomy.According to the reporter: there were gaps in the vessel that did not get stapled as it should have.The staple line was incomplete.The procedure was converted to open.The tissue was very thick and the surgeon heard the handle crack.He stated that the staples didn't form correctly.There was blood loss of around 500cc that there were able to control by going to a more open approach.The bleeding was controlled by suturing.No buttress material was used.No add'l tissue loss and no increase in procedure time greater than 30 minutes.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDO GIA UNIVERSAL 12MM SINGLE USE INST
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP, FORMERLY US SURGICAL A; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3904215
• MDR Text Key: 4428697
• Report Number: 1219930-2014-00422
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 030449
• Device Lot Number: N3K1561X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention