MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA 60 ARTICULATING MED/THICK SULU

Model Number EGIA60AMT

Device Problems Air Leak (1008); Torn Material (3024)

Patient Problems Inflammation (1932); Tissue Damage (2104)

Event Date 02/04/2015

Event Type  Injury  

Event Description

Procedure: lobectomy.Customer states that after fired idrive with the egia60amt to right lower lobe, the tissue around the root of the jaws tore and the torn tissue attached to the end of the cartridge fork.Also, it was confirmed that air leaked from the staple line, doctor fired additionally to the tissue.The staple line was oversawed and treated with tissue adhesive.The customer says that the lung was very inflamed before surgery.Operating time extended: more than 30 min.Nothing fell into the cavity.Under 200 cc bleeding occurred.The procedure was completed and the patient is in good condition.

Manufacturer Narrative

(b)(4).

• Brand Name: EGIA 60 ARTICULATING MED/THICK SULU
• Type of Device: EGIA 60 ARTICULATING MED/THICK SULU
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4636074
• MDR Text Key: 5758306
• Report Number: 1219930-2015-00228
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention