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 Problem Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  Injury  

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 and no extension of surgery time by more than 30 minutes.There was no blood loss of more than 500cc, no unanticipated loss or irreversible damage tissue, and nothing fell into the patient cavity.The defect was found post-op., within 72 hours from surgery.There was bleeding.Therefore, there was an extension of the hospital stay and drug treatment.The current health conditions of the patient is good.

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: 4943285
• MDR Text Key: 6036689
• Report Number: 2647580-2015-00542
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2015

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?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• 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): Other
• Patient Age: 65 YR