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

Model Number EEA28

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: after a low anterior resection procedure, a leakage was found.The leak was discovered when fecaloid matter was seen in the jp drain.The staple line was complete and the staples had formed correctly.The donuts were also complete.The patient was reopened and sutures were used to repair the leakage.The patient had an extended hospital stay due to reoperation to fix the leakage.

• 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: 6067879
• MDR Text Key: 58795494
• Report Number: 2647580-2016-00892
• 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: Physician
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P5D0485KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention