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

Model Number	SIG60CTAMT
Medical Device Problem Codes	Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in a laparoscopic right lower lobectomy, when the surgeon was stapling the bronchus of the right lower lung, the surgeon fired the device with the gray toggle button until complete, but there was poor staple formation.Part of the reload fired in the correct staple formation, but a portion of the fired staples did not form.The staples deployed in the unformed shape.The clear pushers were visible at the beginning of the reload, closest to the hinge, and there were excess proper b-shaped staples, but then in the middle of the reload there were partial deployment of staples that did not form at all.The reload also did not cut at the distal end.The staple line was incomplete distally.A few staples fell and were scattered around the staple line.An additional reload was used to finish the transection at the distal end.Several other reloads were fired and used with same handle and adapter and had no issue.
Additional Manufacturer Narrative
Sigphandle, sig power sigphandle handle (sn# (b)(6)) sigadaptstnd, sig power sigadaptstnd linear adapter (sn# (b)(6)) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A visual inspection of the returned photos noted one 60mm curved tip intelligent reload and two unidentified reloads.Loose formed staples could be seen in the proximal end of the 60mm curved tip intelligent reload.The staple pushers were up proximally.The staples protruded from the staple cartridge at the 3cm cut line.The purple unidentified reload had staple pushers up proximally.The tan reload could not be properly examined.Several loose formed and unformed staples could be seen in the resected tissue.Several staples in the staple line did not appear to properly form.The visual inspection of the returned device found that the reload was partially fired to the 2.5cm cut line.The clamping mechanism was deformed.Functional testing found, when the reload was loaded into a representative instrument, that the interlock was overridden.The reload was applied to test media.All remaining staples were placed and test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the staples did not form properly, a component disengaged, and the staple line was incomplete.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, the staples may not form properly and the tissue may not be fully transected.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.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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19305824
• Report Number: 1219930-2024-02073
• Device Sequence Number: 6598961
• Product Code: GDW
• UDI-Device Identifier: 10884521543683
• UDI-Public: 10884521543683
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: SIG60CTAMT
• Device Catalogue Number: SIG60CTAMT
• Device Lot Number: N4B1706Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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
• Patient Sex: Male