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

Catalog Number EGIAUSTND

Device Problems Misfire (2532); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2014

Event Type  Injury  

Event Description

Procedure: ladg - laparoscopic assisted distal gastrectomy.According to the reporter: at the second firing the knife blade stopped in the middle way and could not complete the firing.Opening another sulu and no problem was confirmed to complete the case.Reported the double stapling part by the first and second firing was slightly torn but it could be recovered by use of v-loc suture product.Operating time not extended.No patient harm.It is unknown if reinforcement material was used.

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
• 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: 3940791
• MDR Text Key: 15993921
• Report Number: 2647580-2014-00492
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083519
• 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
• Report Date: 06/13/2014

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 Catalogue Number: EGIAUSTND
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: LOT NUMBER N4A1672KX, EXP. DATE: 01/31/2019,; MANUFACTURE DATE: 01/2014, K083519; EGIA 60 ARTICULATING MED/THICK SULU, EGIA60AMT,
• Patient Outcome(s): Required Intervention