MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number SIGTRS45AXT

Device Problems Air Leak (1008); Misfire (2532); Separation Failure (2547); Failure to Form Staple (2579)

Patient Problem Tissue Damage (2104)

Event Date 11/08/2017

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 lobectomy.The doctor felt he had fully fired the reload, but the buttress material was not fully cut until the end and there was 1/4 of the staples that did not deploy.The staple line was incomplete.There was further stapling needed due to the buttress material still being attached to the new staple line and the reload.An attempt was made to pull the two apart which caused tissue damage to the lung.Additional staple reloads were used to secure air leak.The health of this patients lungs were in very poor condition.The tissue was very friable.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 1cm cut line.Functionally the reload was loaded into a post market vigilance instrument, the interlock was over ridden, and the reload was applied to test media.All remaining staples were placed, and test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Replication of the partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the loading unit will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection, and prevent patient harm.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: TRI-STAPLE 2.0
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN; 195 mcdermott road; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN; 195 mcdermott road; north haven CT 06473
• Manufacturer Contact: sharon ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7157689
• MDR Text Key: 96214582
• Report Number: 1219930-2018-00012
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

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 Model Number: SIGTRS45AXT
• Device Catalogue Number: SIGTRS45AXT
• Device Lot Number: 7271099NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/24/2018
• 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: Initial
• Patient Sequence Number: 1