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

Model Number	SIGRADXT
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Form Staple (2579); Failure to Cut (2587)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter during the exploratory laparotomy with sigmoid resection, when on transection of the sigmoid colon, the shipping wedge was difficult for the scrub tech to remove.The reload was then properly loaded onto adapter with ease.The reload was placed around sigmoid tissue.The powered device read zone 2 on the oled screen.Surgeon waited 30 seconds to allow edema to disperse from tissue prior to firing.The safety button was pressed and fired.Once reload signaled completed firing the surgeon pressed up on the device toggle to retract knife blade, open jaw of radial reload and remove reload from tissue.Upon doing so, the surgeon realized the knife blade never cut the tissue.Looking at the reload, it looked as if there were staples that were deployed properly, and some had not been deployed into the tissue because they are still in the reload being sent back.Some are malformed as they are sticking out of the reload.The power handle never once signaled excessive force reading.The firing stayed on the line of zone 2 & 3.To resolve the issue, additional resecting and re-stapling was performed.
Additional Manufacturer Narrative
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
Correction: b5, rfr code.Additional information: g3.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.
Event or Problem Description
According to the reporter, during the exploratory laparotomy with sigmoid resection, the shipping wedge was difficult for the scrub tech to remove.The reload was then properly loaded onto adapter with ease.The reload was then placed around sigmoid tissue, when on transection of the sigmoid colon, the powered device read zone 2 on the oled screen.Surgeon waited 30 seconds to allow edema to disperse from tissue prior to firing.The safety button was pressed and fired.Once reload signaled completed firing the surgeon pressed up on the device toggle to retract knife blade, open jaw of radial reload and remove reload from tissue.Upon doing so, the surgeon realized the knife blade never cut the tissue.Looking at the reload, it looked as if there were staples that were deployed properly, and some had not been deployed into the tissue because they are still in the reload being sent back.Some are malformed as they are sticking out of the reload.The power handle never once signaled excessive force reading.The firing stayed on the line of zone 2 and 3.To resolve the issue, additional resecting and re-stapling was performed.
Additional Manufacturer Narrative
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
Additional information: 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 reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible along one-half of the cartridge, starting from the proximal end.No shipping wedges were received with the listed reloads.Functionally, the reload was loaded into a handle, recognized as used, and was loaded into a representative instrument.The interlock was overridden and the reload was applied to test media.All remaining staples were placed, the reload was cycled without hesitation or binding, and test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the device had no cut, the shipping wedge was difficult to remove, and there was a staple formation issue.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of partial firing.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: 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 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: 20470009
• Report Number: 1219930-2024-04916
• Device Sequence Number: 7519251
• Product Code: GDW
• UDI-Device Identifier: 10884521543751
• UDI-Public: 10884521543751
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 01/17/2025

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: SIGRADXT
• Device Catalogue Number: SIGRADXT
• Device Lot Number: N3D0308Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 11/05/2024; 01/06/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 10/25/2024; 11/08/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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 Age: 88 YR
• Patient Sex: Male