MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number 030458

Device Problems Air Leak (1008); Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fever (1858); No Code Available (3191)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient underwent a laparoscopic gastric bypass procedure.No issues were observed with the stapling during the procedure.A device component fell into the cavity of the patient.The next day a leak (tightness) test was performed.The blue methylene came out in spurts showing a dehiscence had occurred.A reoperation was performed.Parenteral nutrition and a subsequent placement of an esophageal endoprosthesis was performed.The patient is feverish.The patients hospitalization time was extended.There was no patient injury.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient underwent a laparoscopic gastric bypass procedure.No issues were observed with the stapling during the procedure.The next day a leak (tightness) test was performed.The blue methylene came out in spurts showing a dehiscence had occurred.A reoperation was performed.Parenteral nutrition and a subsequent placement of an esophageal endoprosthesis was performed.The patient is feverish.The patients hospitalization time was extended.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7589551
• MDR Text Key: 110700491
• Report Number: 1219930-2018-03031
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002898
• UDI-Public: 10884523002898
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 030458
• Device Catalogue Number: 030458
• Device Lot Number: N7L0768KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• Date Device Manufactured: 11/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention