MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIAADAPT
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when cutting the colon during laparoscopic right hemicolectomy, the reload got stuck on the colon and would not open.It took time to take the reload out.The surgeon inserted another handle and cut the part of the reload that got stuck on the colon.The event resulted to an unanticipated tissue loss and surgical time extended to 30 minutes.The incision was also extended.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the firing rod pulled through the laminates of the reload during retraction, preventing the knife blade from retracting and leading to the lock on tissue.The issue was resolved by inserting the manual retract tool.It was turned clockwise to retract the firing rod to the home position, depressed the unload button, and removed the reload and trocar.Damage was noted on the firing rod tip which is indicative of the firing rod pulling out of the lock.The adapter was disassembled and damage to the side wall of the non-welded tip housing was seen.This damage likely occurred as a result of the broken reload.There was no damage noted to the lockout slider.It was reported that the jaws of the device remained closed on tissue after firing.The reported issue was confirmed.The most likely cause was not traced to the device.This issue can occur when firing the reload fully articulated on over-indicated tissue or over an obstruction.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.
Event or Problem Description
According to the reporter, when cutting the colon during laparoscopic right hemicolectomy, the reload got stuck on the colon and would not open.It took time to take the reload out.The surgeon inserted another handle and cut the part of the reload that got stuck on the colon.The event resulted to an unanticipated tissue loss and surgical time extended to 30 minutes.The incision was also extended.
Additional Manufacturer Narrative
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: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10227457
• Report Number: 1219930-2020-02628
• Device Sequence Number: 18981213
• Product Code: GDW
• UDI-Device Identifier: 10884521142800
• UDI-Public: 10884521142800
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/28/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/17/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention