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

Model Number SIGTRS60AXT

Device Problem Separation Failure (2547)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 03/31/2020

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 first firing on a laparoscopic distal pancreatectomy, the tip of the sheet on the anvil side (dorsal side of the pancreas) had not been placed on the pancreas used for the resection.Although there was no sheet on the item collected, the surgeon completed the procedure with three stitches sutured to the part where there was no sheet placed.The surgical time was extended by less than 30 minutes.There was oozing bleeding occurred as a result.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was fully fired.Staple pushers were visible at the zero cut line.All sutures were released and no trs material was left on the device.Functionally the reload was loaded into a pmv representative instrument and was cycled without hesitation or binding.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 9960999
• MDR Text Key: 187687769
• Report Number: 1219930-2020-01740
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543614
• UDI-Public: 10884521543614
• 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: 05/21/2020

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: SIGTRS60AXT
• Device Catalogue Number: SIGTRS60AXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention