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 05/05/2021

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 device was partially fired.Functional testing required the interlock to be overridden.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.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: in the event of an incomplete firing of the endo gia¿ reinforced reload with tri-staple¿ technology, the distal maxon¿ anchoring sutures used to secure the staple line reinforcement material to the anvil and cartridge may not be released, the inability to release the distal anchor suture will prevent the jaws from opening fully when the device is unclamped.The remaining intact staple line reinforcement material on the reload will need to be removed from the device by gentle traction and/or by cutting the anchor suture with scissors.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when surgeon was creating the sleeve on the second firing, in a laparoscopic sleeve gastrectomy, the reload retracted back automatically before going all the way to the end.The next reload fired to the end but did not cut the suture at the distal end.Surgeon got another reload and then did another firing using another reload to continue the firing.No patient injury.Medtronic's initial evaluation of the incident is that an analysis of the system logs noted that the device was found to be partially fired.

• 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: 12099513
• MDR Text Key: 259376017
• Report Number: 1219930-2021-02626
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2021

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: 02/29/2024
• Device Model Number: SIGTRSB60AMT
• Device Catalogue Number: SIGTRSB60AMT
• Device Lot Number: N1C0771Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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