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 Problem 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; after use of the device during a low anterior resection procedure, a leak was detected by means of a barium test.The patient's colostomy had to be reopened in order to address the issue, increasing the duration of the hospital stay.The patient has since been released from the hospital.According to the doctor, the staple lines were intact and there was no issue with the staple formation.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one 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 of the staple guide noted the instrument was fully applied.The anvil of the instrument was observed to be tilted and attached to the instrument.A microscope examination of the device displayed nicks on the knife blade.Functionally, the device was reloaded with a full complement of staples and applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, despite the noted knife blade damage and the staple line was properly formed.As noted in the safety medical assessment.Should new information become available, the file will be re-opened and reassessed at that time.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one device opened by the account.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 of the staple guide noted the instrument was fully applied.The anvil of the instrument was observed to be tilted and attached to the instrument.A microscope examination of the device displayed nicks on the knife blade.Functionally, the device was reloaded with a full complement of staples and applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, despite the noted knife blade damage and the staple line was properly formed.As noted in the safety medical assessment, the doctor reported that the staple line was intact and the staple formation was acceptable during the procedure.Should new information become available, the file will be re-opened and reassessed at that time.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6080808
• MDR Text Key: 59218945
• Report Number: 2647580-2016-00922
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P6D0507KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention