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

Model Number	SIG45CTAVM
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: egiaushort, egiaushort endogia ultra univ sht stap (lot# p4e0902) 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 a right upper lobectomy, on the right superior pulmonary vein, after firing, it was difficult to retract the return knob.An additional resection and suture were performed with a stapler to resolve the issue.There was an extension of surgery time of 30 minutes.
Additional Manufacturer Narrative
Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the reload was attached to the listed instrument (707052080-10).The reload was fully fired and engaged in interlock.The reload was slightly bent to the side.The jaws of the reload were clamped.The knife bar assembly was partially advanced.All staples were fired, formed, and found between anvil and cartridge.A white strand and tissue could be seen in the jaws.Microscopic inspection revealed damage to the knife blade.Functional testing found that the reload jaws were manually opened.The reload was removed from the listed instrument.The reload was loaded into a representative instrument (0736).The jaws were clamped and unclamped repeatedly without difficulty.The interlock was overridden and the reload was then cycled without hesitation or binding.The test media was transected.The reload interlock was tested and found to function properly.It was reported that the knife blade was difficult to retract.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur under the following conditions: the shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod extended.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the sulu engages in the instrument to facilitate clamping and unclamping.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: do not attempt to remove the shipping wedge until the sulu is loaded into the instrument.Ensure that the black return knob on the instrument is pulled back completely and the articulation lever is neutral (0° relative) to the instrument.Cycle the instrument to confirm proper loading of the reload.To do so, squeeze the handle once to close the jaws of the reload.Push the black loop handle all of the way forward or pull back on the black return knob and confirm that the reload jaws open fully.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: 20351841
• Report Number: 1219930-2024-04596
• Device Sequence Number: 18169729
• Product Code: GDW
• UDI-Device Identifier: 10884521543720
• UDI-Public: 10884521543720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: SIG45CTAVM
• Device Catalogue Number: SIG45CTAVM
• Device Lot Number: N3H2341Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown