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

Model Number SIG45CTAVM

Device Problem Retraction Problem (1536)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: egiaustnd, egiaustnd endogia ultra univ std stap (lot#p2k0024) sig45ctavm, tri 2.0 sig45ctavm 45 ct vsclr med 12mm (lot#n2k0704y) 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 sigmoid colectomy, during division of pedicle, the first handle was used without any issue during the first and second firing.When the same handle and a third reload was being cycled prior to be handed off, there was a loud pop when the cartridge was opened.Another same reload was opened but the same thing happened.Handle was replaced with a new one and the two reloads were also loaded; but the popping noise was heard each time.One cartridge was fired on the back table with good formation but the surgeon noticed that it was stiffed to open after firing.The second cartridge was loaded and fired on tissue with good staple formation but it was also stiff to open.It was noted that the stiffness was retracting the black knobs to open the jaws required more force than normal, while cycling the stapler and after the cartridge was fired.A new reload was opened and used with the second handle without an issue.No patient injury.

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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that after firing the device, there was resistance while attempting to retract the knife.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: 17477259
• MDR Text Key: 320591257
• Report Number: 1219930-2023-03366
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543720
• UDI-Public: 10884521543720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIG45CTAVM
• Device Catalogue Number: SIG45CTAVM
• Device Lot Number: N2K0704Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2022
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 186 KG