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

Model Number SIGTRS60AXT

Device Problems Entrapment of Device (1212); Misfire (2532); Separation Failure (2547); Failure to Form Staple (2579)

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

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a thoracoscopic lung resection, used for lung parenchymal resection, the reload was loaded to the handle and used then the handle became stiff halfway, and it became unable to be squeezed.The most distal side of the staples were found to be u-shaped.The jaws were also locked on tissue.As the firing became unable to be perfomed halfway, the reinforced sheet was cut and separated with scissors and removed from the tissue.The same event happened when replace the reload.After that, the tissue was separated by another handle and reload, from the part which had been stapled in the halfway.There was no patient injury.

Manufacturer Narrative

Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device was found to be partially fired, the knife laminates were found to be damaged, the jaw of the reload was open, the device had a deformed clamping mechanism, and staple pushers were flush with the cartridge.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 the device initially fires but failed to complete the firing cycle, and the reinforcement material did not release from the device as expected after firing.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.It was also reported that the staples did not form as expected, and the jaws of the device remained closed on tissue after firing.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.Always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ ultra universal short, endo gia¿ ultra universal or endo gia¿ ultra universal xl stapler.Overly thick or thin tissue may result in unacceptable staple formation.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 11197124
• MDR Text Key: 228169489
• Report Number: 1219930-2021-00282
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543614
• UDI-Public: 10884521543614
• Combination Product (y/n): N
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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: 01/31/2023
• Device Model Number: SIGTRS60AXT
• Device Catalogue Number: SIGTRS60AXT
• Device Lot Number: N0B0959Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1