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

Model Number SIGTRSB60AXT

Device Problems Separation Failure (2547); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

According to the reporter, during the laparoscopic gastric sleeve, on stapling the gastric sleeve, the surgeon felt that the reinforcement material was not releasing properly post firing and opened jaws.The surgeon still continued to use the devices to complete the procedure.There was no patient injury.

Manufacturer Narrative

D10 concomitant products: sigtrsb45amt, sigtrsb45amt 45mm med thk reinforced rel, (lot #n2d0495y) sigphandle, sig power sigphandle handle, (serial #: unknown) unk-sigadapt, unknown signia egia adapter, (serial #unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted the reload was clamped onto tissue and the i beam was retracted.The jaws were opened.The reload was pulled and it was stuck to the tissue.A grasping instrument was used to pull tissue away from the reload.The distal anvil suture was still attached to the reload.It was reported that the jaws will not close.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that transverse rupture strength (trs) material did not release.The reported issue was 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 medtronic 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: 18407196
• MDR Text Key: 331681610
• Report Number: 1219930-2023-05383
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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
• Device Lot Number: N2F0554Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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
• Treatment: SEE H10
• Patient Sex: Female