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

Model Number SIGTRSB60AMT

Device Problems Misfire (2532); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the returned device to be pre-fired and engaged in interlock.Functional testing required the interlock to be overridden and the reload was applied to test media.The reload interlock was tested and found to function properly.It was reported that after firing, the reinforcement material did not release from the device as expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue 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 reload will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection to prevent patient harm.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on a laparoscopic sleeve gastrectomy, during the division of stomach, after the reload was fully fired, the retention suture did not release the buttress material.The buttress material was cut free from the reload.There was no patient injury.Medtronic¿s initial evaluation of the incident device found that the reload was partially fired to the 1cm cut line with the interlock engaged.

• 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: 13479836
• MDR Text Key: 285228675
• Report Number: 1219930-2022-00457
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717626
• UDI-Public: 10884521717626
• 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: 02/08/2022

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: SIGTRSB60AMT
• Device Catalogue Number: SIGTRSB60AMT
• Device Lot Number: 1210024NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2022
• Initial Date FDA Received: 02/08/2022
• 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
• Patient Sex: Female