MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA 60 ARTICULATING MED/THICK SULU; DISPOSABLE SURGICAL STAPLER

Model Number EGIA60AMT

Device Problem Torn Material (3024)

Patient Problem Injury (2348)

Event Date 10/14/2014

Event Type  Injury  

Event Description

Procedure: sleeve gastrectomy.According to the reporter: when purple reload was used, the edges of tissue tore.The posterior wall of the gastric antrum was torn.No other procedure was performed.The tear was corrected with a stitch using polydioxanone continuous suture needle 3/0 26mm.There was patient harm.The surgery time was not extended.There was not any blood loss of 500cc.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: EGIA 60 ARTICULATING MED/THICK SULU
• Type of Device: DISPOSABLE SURGICAL STAPLER
• 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: 4294660
• MDR Text Key: 5080166
• Report Number: 1219930-2014-01119
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K083519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: N4C0094KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention