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

Model Number SIGTRS60AMT

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

Patient Problem No Code Available (3191)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopy low anterior resection surgery, handle and reload were able to be set without any problems, and there was no problem with the firing, but the anchoring suture was not cut.In addition, regarding the reload, some staples were found to be remained on the tip side, and there was a possibility that the handle did not squeezed until the end.One part of the tissue could not be resected, so additional resection was performed with another reload to deal with the problem.

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Visual inspection identified that it was partially fired to the 1cm cut line.The proximal sutures were cut.The distal cartridge and anvil sutures were still anchored with small pieces of reinforcement material attached.Staple pushers were visible at the 1cm cut line indicating the point where the handle compression had stopped.Functional testing found that when applied to test media, all remaining staples were placed and the media was cleanly transected.The distal sutures were released as the reload was fully fired, and the safety interlock feature successfully prevented the reload from firing a second time.It was reported that the staples did not form properly and the trs material did not release.A related device issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the reload will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection to prevent patient harm.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet 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
• MDR Report Key: 9960966
• MDR Text Key: 187687441
• Report Number: 1219930-2020-01738
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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
• Device Operator: Health Professional
• Device Model Number: SIGTRS60AMT
• Device Catalogue Number: SIGTRS60AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention