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

Model Number SIGTRSB60AXT

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 08/25/2020

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 had damage to the cutting edge of the knife blade consistent with application over an obstruction.The reloads were loaded into a representative instrument.The interlocks for reloads ""1"" and ""2"" were overridden and all reloads were applied to test media.All respective remaining staples were placed, and test media was transected.Functionally, the 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 if the returned device had been applied on tissue beyond the indicated range.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: always select a reload with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Ensure tissue has not extended (extruded) beyond the tissue stop proximally.Tissue forced into the instrument beyond the tissue stop may be transected without stapling.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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.The use of curved tip reloads is contraindicated on tissue or structures that cannot fit completely within the jaws proximal to the transitional angle of the curved tip.Placement of tissue proximal to the tissue stops (on the reload) may result in stapler malfunction.Any tissue extending beyond the cut line will not be transected.In case of a curved tip reload, ensure that the tissue/vessel to be transected does not extend beyond the black cut line on the reload.The device will only cut to the black cut line.Tissue contained within the jaws distal to this line will not be transected.The curved tip reload cannot be used for blunt dissection with the introducer attached.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when firing during a laparoscopic robotic sleeve gastrectomy, the staple lines were good and closed completely but the stay suture at the end of the reload was not cutting.A new reload from another lot was used.There was no patient injury.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10972540
• MDR Text Key: 220669174
• Report Number: 1219930-2020-05105
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2020

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: 03/31/2022
• Device Model Number: SIGTRSB60AXT
• Device Catalogue Number: SIGTRSB60AXT
• Device Lot Number: N9D0548Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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