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

Model Number EEA25

Device Problem Defective Component (2292)

Patient Problems Death (1802); Fistula (1862)

Event Date 06/26/2015

Event Type  Death  

Event Description

Procedure: esophagus.According to the reporter: the procedure was performed without complications.No reinforcement material was used in conjunction with the stapling device.There was no patient injury.There was no extension of the surgery time by more than 30 min., no blood loss of more than 500cc, and no unanticipated loss or irreversible damage tissue.Nothing fell into the patient cavity.A defect was found post-op.Within 72 hours from surgery.A fistula was found.The patient has been brought back to the operating room for prosthesis implant.As such, there was an extension of the hospital stay and drug treatment.Confirmation was received that the patient died on (b)(6) 2015.

Manufacturer Narrative

(b)(4).

• Brand Name: EEA 25MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE STAPLING DEVICE
• 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: 4943603
• MDR Text Key: 21560242
• Report Number: 2647580-2015-00543
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2015

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: 09/30/2019
• Device Model Number: EEA25
• Device Catalogue Number: EEA25
• Device Lot Number: P4J0668KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR