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 Unspecified Tissue Injury (4559)

Event Date 03/28/2022

Event Type  Injury  

Event Description

According to the reporter, during the laparoscopic sleeve procedure, on second firing, the stapler stopped in the middle of firing and indicated excessive force.The staples did not form and there was an incomplete staple line distally.The surgeon first cut out the reinforcement material from the incomplete firing and then tried another handle and received the same excessive force message.The staple line was fixed through over sewing and leak test was performed.Then, a manual handle was opened and fired the rest of the case with reloads of the same lot number.Tissue damage was also noted.

Manufacturer Narrative

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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14118308
• MDR Text Key: 289333639
• Report Number: 1219930-2022-01315
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717633
• UDI-Public: 10884521717633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGTRSB60AXT
• Device Catalogue Number: SIGTRSB60AXT
• Device Lot Number: N1M0835Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/15/2022
• Date Device Manufactured: 12/30/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female