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

Model Number SIGTRSB60AXT

Device Problems Material Rupture (1546); Separation Failure (2547); Failure to Form Staple (2579)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Breakdown (2681)

Event Date 08/23/2023

Event Type  malfunction  

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.

Event Description

According to the reporter, during a laparoscopic single anastomosis duodenal-ileal (sadi) bariatric surgery, during the first firing on the stomach antrum, the stapler fired uneventfully, without a problem.The knife blade returned, and the jaws opened without an issue.When removing the opened staple load from the tissue, the entire reinforcement material on the anvil side peeled off from the staple line and was remained attached to the staple reload.Upon further inspection, the distal retaining suture on the anvil side did not cut with the knife blade.It appeared that the deployed staples pulled through the trs when the stapler was being removed.Some staples did not form completely when the reinforcement malfunctioned.There was slightly more bleeding than normal, which was touched up with cautery.Surgeon chose to over sew the staple line with a 3/0 suture to imbricate.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one device opened and outside of its packaging.The jaws were open and the staple pushers were up distally.The distal cartridge suture was attached and the cartridge side reinforcement material was loose.The material was partially torn and a piece appeared missing.Holes were noted in the reinforcement material and tissue appeared sutured.A piece of material could be seen in the jaws and staple formation was difficult to see due to image quality.It was reported that the staples did not form as expected.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that after firing, the reinforcement material did not release from the device as expected and the reinforcement material was torn.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medt ronic quality specifications.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
• Type of Device: 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: 17730877
• MDR Text Key: 323205034
• Report Number: 1219930-2023-03848
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717633
• UDI-Public: 10884521717633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGTRSB60AXT
• Device Catalogue Number: SIGTRSB60AXT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male