MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 25MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEA25

Device Problems Failure to Form Staple (2579); Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information not provided.Udi not provided.Re-processing information not provided.Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

During procedure, the reload shot the staples line but the staples didn't make the "b" shape, and the tissue wasn't cut.So they decide to remove the staples line and suture manually.There is no patient harm.

Event Description

Additional information provided: the stapler did not make the donut.The stapler partially fired but did not release staples.Staples fell into the patient's cavity and were removed.

• Brand Name: EEA 25MM SINGLE-USE STAPLER
• Type of Device: STAPLER, SURGICAL
• 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: 6186369
• MDR Text Key: 62746365
• Report Number: 2647580-2016-01113
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

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: 01/31/2020
• Device Model Number: EEA25
• Device Catalogue Number: EEA25
• Device Lot Number: P5A0193KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR