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

Model Number SIGTRSB60AXT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of two photographs of a reinforced reload.A visual inspection of the returned photos noted that both distal sutures appear intact.The torn material was properly anchored to the anvil and cartridge at the distal end.Due to the image quality the cartridge face, staples, and staple pushers cannot be clearly seen.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic sleeve gastrectomy procedure, during second firing of stapler of the stomach, the staples were not all fired and formed properly.It was reported that the distal tip of the reinforcement was not laid on the tissue and was stuck in the reload.It was noted that there was also an incomplete staple line.Another reload was used to complete the procedure.There was no patient injury.

Manufacturer Narrative

Additional information: d4(serial#), d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device and a photographic evaluation of two photographs of a reinforced reload.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 4cm cut line.The distal sutures were still intact.There was reinforcement material left on the distal sutures.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.A visual inspection of the returned photos noted that both distal sutures appear intact.The torn trs material was properly anchored to the anvil and cartridge at the distal end.Due to the image quality the cartridge face, staples, and staple pushers cannot be clearly seen.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all 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.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9642305
• MDR Text Key: 176818400
• Report Number: 1219930-2020-00494
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717633
• UDI-Public: 10884521717633
• Combination Product (y/n): N
• PMA/PMN Number: K173270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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: 06/30/2022
• Device Model Number: SIGTRSB60AXT
• Device Catalogue Number: SIGTRSB60AXT
• Device Lot Number: N9G0645Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2020
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1