MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIA ULTRA UNIVERSAL STAPLER; DISPOSABLE SURGICAL STAPLER

Model Number EGIAUSTND

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Procedure: jejunostomie.According to the reporter: before using the instrument a piece of the tip was missed.Was there any irreversible tissue damage as a result of this problem? no i solved the problem by cutting out the anastomosis and move 2 cm's higher up on the esophagus.A new e-e esophago-jejunostomy was used unanticipated extension of the incision by more than one inch? no unanticipated blood loss of 500ccs or more? no was surgical time delayed by more than 30 minutes due to the product problem? no device fragment or component falling into the patients cavity ? no device fragment left in the patient? no if applicable, what was done to correct this condition? (be specific e.G.Cautery, sutured, applied another device, etc.) another device eea 25mm4.8 xl.

Manufacturer Narrative

(b)(4).

• Brand Name: EGIA ULTRA UNIVERSAL STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4242705
• MDR Text Key: 5065498
• Report Number: 2647580-2014-00973
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K083519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P4A0338X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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): Disability