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

Model Number	SIGC60VM
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, on a laparoscopic sleeve gastrectomy, during stomach transection, the device fired but the entire staple line of 5 reloads were bleeding.There was poor staple formation.The entire staple line was clipped to stop the bleeding.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D10 concomitant product: sigc60vm, ri 2.0 sigc60vm 60 vsclr med cartridge (lot#n1c0014y); sigc60vm, ri 2.0 sigc60vm 60 vsclr med cartridge (lot#n1c0014y); sigc60vm, ri 2.0 sigc60vm 60 vsclr med cartridge (lot#n1c0014y); sigc60vm, ri 2.0 sigc60vm 60 vsclr med cartridge (lot#n1c0014y); siglu60a, tri 2.0 siglu60a 60 load unit (serial#unknown); unk-egiaadapter, unknown egia adapter (serial#unknown).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the staple cartridge was fully fired with the sled fully advanced.The cartridge shield on the proximal end of the cartridge assembly (opposite the cartridge connecter chip) was detached from the proximal end of the cartridge assembly.The proximal end of the cartridge assembly (where the cartridge shield attaches to the cartridge assembly) was found to be damaged at the proximal end of the device cartridge assembly.It was reported that the staples did not form as expected and there was unexpected bleeding occurred along the staple line.The reported issues were confirmed.The most likely cause was not traced to the device.The evaluation detected an unreported condition: the smart chip was damaged.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: prior to firing, ensure that the tri-staple¿ 2.0 intelligent cartridge is completely embedded into the channel of the signia¿ intelligent loading unit.Do not try to load a tri-staple¿ 2.0 intelligent cartridge in the signia¿ intelligent loading unit if the cartridge cover is missing or misaligned.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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14837680
• Report Number: 1219930-2022-02429
• Device Sequence Number: 17341813
• Product Code: GDW
• UDI-Device Identifier: 10884521543560
• UDI-Public: 10884521543560
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: SIGC60VM
• Device Catalogue Number: SIGC60VM
• Device Lot Number: N1C0014Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown