MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 25MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEAXL25

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter phone number: (b)(6).Contact office phone number: (b)(4).

Event Description

Procedure: gastrectomy.Per the reporter: it was not possible to connect the pressure plate of the orvil with the eeaxl.Device.The procedure was change from endoscopic to an open surgery and completed with a standard 25 dst eea.No person injured, the surgery was extended more than 30min, no blood loss, no loss or damage to tissue, nothing fell into patient, no reinforcement material used.No patient data available, patient is doing well.

Event Description

Procedure occurred sometime in (b)(6) 2016.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one stapler and one orvil 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 devices.The visual inspection and functional evaluation of the devices had acceptable results.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA XL 25MM 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
• MDR Report Key: 6121218
• MDR Text Key: 60686167
• Report Number: 2647580-2016-00989
• 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,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEAXL25
• Device Catalogue Number: EEAXL25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/20/2016; 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ORVIL, UNKNOWN DATE
• Patient Outcome(s): Other