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

Model Number	SIG30AMT
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the video assisted thoracoscopy surgery wedgectomy, while attempting to staple around tumor lung tissue, the 30 millimeter purple reload fired correctly.The second firing with power handle was 45 millimeter black reload, during this firing, the firing was able to be completed but the surgeon describe the reload as pushing back on the tissue or not fully stapling and cutting the tissue as far as expected based on initial positioning of the reload.On the third 45 millimeter reload firing, the issue occurred again with full firing of the reload but no advancement of the tissue transection occurred.There were more staples built up on the tissue with little to no advancement of the staple cut line.During the fourth firing of another 45 millimeter black reload, the power handle screen showed the excessive thickness after firing to the central portion of the staple line.The surgeon waited to allow the tissue more time to compress and fired further another 1-2 mm and the excessive icon stopped the stapler again.The power handle was unable to advance any further so the stapler was removed.During the fifth firing of another 45millimeter black reload, the same thing occurred as the fourth firing.The next 6 through 12 firings were done with nine manual handles using 45 millimeter black reload and 60 millimeter black reload.It was mentioned that the staple line was incomplete centrally using 60 millimeter reloads and the staple line did not appear to be divided in the central to distal portion.Some staples partially began to fire but the handles cracked within a couple millimeters.Another handle also cracked during firing forcibly.Some staples were not able to successfully form on the tissue, some are partially formed and unformed staples were able to advance before the handle cracked.All handles appeared to experience the same excessive force by cracking the handle.Scissors were used to remove excess staples form previous firings.The last three firings 13-16 reloads were in order of two 45 millimeter black reloads and 45 millimeter arti culating purple reload to complete the staple line.Multiple staple reloads and handles were used to complete the staple line successfully and resolve the issue.A suture was also used to over-sew the patient side staple line.Medtronic's initial evaluation of the incident detected the unreported condition of thick tissue.The clamping mechanism was deformed.
Additional Manufacturer Narrative
D10 concomitant products: sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot #n2j0628y) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot #n2d0415y) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot n2g0725y) egia45amt, egia45amt egia 45 artic med thick sulu, (lot #p3a0288) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot #n2h0727y) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p3c0334) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p3d0421) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p3c0608) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p2h0183) sigadaptshort, sig power sigadaptshort lin short adapt, (serial #(b)(6)) sigphandle-rfb, sig power handle sigphandle-rfb, (serial #(b)(6)) sigpshell, sig power sigpshell control shell, (lot #unknown) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #unknown) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot #unknown) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot #unknown) sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot #unknown) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot #n2h0727y) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot #n2h0727y) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot #n2h0727y) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot #n2h0727y) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p3c0334) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #p3c0334) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #unknown) egiaustnd, egiaustnd endogia ultra univ std stap, (lot #unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was fully fired.The clamping mechanism was deformed.Staple pushers were flush with the cartridge.Functionally, the reload was loaded into a representative handle.The handle recognized the reload as unused.The loading unit was then loaded into a representative instrument.The interlock was overridden, the loading unit was cycled without hesitation or binding and was applied to test media.The interlock was tested and found to function properly.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.No information regarding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that of thick tissue.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: always select a reload with the appropriate staple size for the tissue thickness.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
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18624585
• Report Number: 1219930-2024-00523
• Device Sequence Number: 17996275
• Product Code: GDW
• UDI-Device Identifier: 10884521543652
• UDI-Public: 10884521543652
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: SIG30AMT
• Device Catalogue Number: SIG30AMT
• Device Lot Number: N2J0020Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown