MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEA28

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

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

According to the reporter, during a colectomy procedure, they performed the anastomosis but one hour later there was bleeding and the patient had to be re-operated in order to suture the open vessel using a clip.There was less than 500 bleeding.No tissue damaged or loss.The surgeon informs that he has the sensation that the blade does not cut properly.They have discarded the clinical sample so we are going to send a representative unit belonging to the same lot and box.

Manufacturer Narrative

(b)(4).

Event Description

Per additional information received, according to the reporter, the last known patient status is good.There were no issues with the staple line after the first procedure.There was no leak test performed after the first procedure, but no bleeding was noticed.The bleeding was discovered after a few hours.The blood loss was less than 500cc.

Manufacturer Narrative

Ftr# (b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one sealed stapler.This evaluation was based on a medical and technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The visual inspection and functional evaluation of the device had acceptable results.The file will be closed as fired satisfactorily as the device was found to meet all visual and functional test specifications.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA 28MM 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 06473 ; 2034925267
• MDR Report Key: 6069772
• MDR Text Key: 58915858
• Report Number: 2647580-2016-00900
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 20884523005537
• UDI-Public: (01)20884523005537
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K111825
• 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,Followup,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P6C0549KQX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention