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

Model Number SIGTRS60AMT

Device Problems Entrapment of Device (1212); Separation Failure (2547)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an open functional end-to-end anastomosis (colon), the device was able to fire with no problem; however, the anchoring suture on the cartridge fork side of the reinforcement cartridge could not be removed, and the sheet did not come off after firing.In addition, the device locked on tissue and the surgeon forcibly pulled the device towards them in able to remove it.There was no problem with the tip of the anastomosis, but the surgeon reinforced it with additional suture just in case.There was no patient injury.Medtronic's initial evaluation of the incident is that an investigation detected an unreported condition of "pivot rivets were not pressed properly" and "reload clamped with shipping wedge" that has no relationship to the reported condition.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device to be partially fired, and the shipping wedge was damaged.Functional testing required the interlock to be overridden and the reload was applied to test media.The reload interlock was tested and found to function properly.It was reported that the jaws of the device remained closed on tissue after firing, and the reinforcement material did not release from the device as expected after firing.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Shipping wedge damage may occur if the shipping wedge pull tab is pulled in a lateral fashion towards the distal end of the sulu (single use loading unit) channel rather than away from the channel, or if the loading unit is clamped prior to removal of the yellow shipping wedge.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: in the event of an incomplete firing of the endo gia¿ reinforced reload with tri-staple¿ technology, the distal maxon¿ anchoring sutures used to secure the staple line reinforcement material to the anvil and cartridge may not be released, the inability to release the distal anchor suture will prevent the jaws from opening fully when the device is unclamped.The remaining intact staple line reinforcement material on the reload will need to be removed from the device by gentle traction and/or by cutting the anchor suture with scissors.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
• MDR Report Key: 12258386
• MDR Text Key: 264465694
• Report Number: 1219930-2021-03118
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543638
• UDI-Public: 10884521543638
• Combination Product (y/n): N
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SIGTRS60AMT
• Device Catalogue Number: SIGTRS60AMT
• Device Lot Number: N1E0015Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1