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

Model Number EEA28

Device Problems Failure To Adhere Or Bond (1031); Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the anastomosis was tight after inspection and tightness test.However, on the 3rd day after the procedure, an insuffency was recognized and had to be corrected in a re-operation.There was poor staple formation.The last known patient status is "well".There was no patient injury.There was no extension of incision.There was no extension of surgery time by more than 30 minutes.There was no unanticipated blood loss, tissue damage or tissue loss.There was no change of procedure from laparoscopy to open surgery.There was no part that fell into cavity.There was no reinforcement material used.The device was not re-sterilized.

• 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, CT 06473 ; 2034925267
• MDR Report Key: 5996043
• MDR Text Key: 56342733
• Report Number: 2647580-2016-00788
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P6A0218KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Required Intervention
• Patient Age: 60 YR