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

Model Number EGIATRS60AMT

Device Problems Misfire (2532); Separation Failure (2547); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter: occurred during a laparoscopic thoracic segmentectomy procedure.The stapling device was being used for resecting the tumor off of the lung.The stapler was able to fire, but the stapler did not fire all the way to the distal end.Stopped approximately four to five millimeters from the distal tip.And did not release the suture on the reinforced reloads, the material was torn loose from the reload.The staple line was incomplete at the distal end.In order to resolve the issue and complete the case, the sutures was cut with shears.There was no patient harm.The patient outcome is alive, no injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the device had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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 mc dermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6961161
• MDR Text Key: 90522102
• Report Number: 1219930-2017-08077
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521191010
• UDI-Public: 20884521191010
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 02/29/2020
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Device Lot Number: N7B0404KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 01/07/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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 Age: 64 YR