MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM); STAPLER, SURGICAL

Model Number EEA28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No further details regarding patient, product or procedure were provided by the reporter.

Event Description

According to the reporter; one to 3 hours after an anastomosis was performed during a sigmoidectomy procedure, 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.No reinforcement material was used.Last patient status is good.The surgeon informs that he has the sensation that the blade did not cut properly.They have discarded the clinical sample.The surgeon provided that a leak test was not performed after the original procedure, because the patient was not bleeding, that there weren't any issues noticed with the staple line after the original procedure and that the surgeon does not think that there were any issues with staple formation.No pictures are available of the issue.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one sealed stapling device.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¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM)
• 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: 6072691
• MDR Text Key: 58944991
• Report Number: 2647580-2016-00909
• 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,health professional,u
• Reporter Occupation: Other Health Care Professional
• 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: 11/02/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention