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

Model Number EGIATRS60AXT

Device Problems Separation Failure (2547); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Date 05/23/2017

Event Type  malfunction  

Event Description

According to the reporter, during a robotic lobectomy procedure, during the firing process, the staples malformed, the reinforced material was not intact, and the suture did not cut.The reinforcement material was stuck in the reload.The reinforcement material needed to be cut off from the device.There was poor staple formation.The staple line was incomplete.On the second reinforced reload, the misfire occurred.There was tissue loss from three staple firing attempts.The tissue loss was the width of a 60mm staple reload.Additional tissue resection was due to the creation of a new staple line.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7020993
• MDR Text Key: 92503072
• Report Number: 1219930-2017-08671
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521191003
• UDI-Public: 20884521191003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: EGIATRS60AXT
• Device Catalogue Number: EGIATRS60AXT
• Device Lot Number: N6J0338KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 11/10/2017
• Date Device Manufactured: 09/12/2016
• 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