MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE

Model Number	TRIEEAXL28XT
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic lower anterior resection, when end to end anastomosis performed, the surgeon forced the safety away from the stapler.It was unknown if the surgeon saw green in the indicator window.The safety would not release so the surgeon forced the safety away and fired the circular stapler which caused the misfire.As a result, there was a poor staple formation, incomplete staple line, the donut was poorly formed, staples fell into the cavity of the patient and the anastomotic site was torn.The procedure was converted to open, the surgeon had to re-transect the colon and divert the patient to an ileostomy.The surgical time was extended 30 minutes or more, and extended the patient hospitalization (2 days) due to the device problem.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the cut ring was partially severed or intact.Functionally, the wing nut and safety functioned properly upon rotating the twist knob.The green bar was visible within the indicator window when the twist knob was fully closed.Pusher-fingers and knife advance when the handle was squeezed and the knife cut the media cleanly and completely.The device also produced all audible, tactile and visual indicators during the functional testing.It was reported that the safety button did not function as intended, a component disengaged from the device into the surgical cavity, the donut formed poorly or was missing completely after firing, operating time was extended by more than 30 minutes resulting from product failure, and the staples did not form as expected and were missing from the staple line after firing.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument handle compression is not completed or if the instrument is applied against an excessive amount of tissue during the clinical application.The manufacturing records for each device are thoroughly re viewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to squeeze the handle fully during firing may result in unacceptable staple formation and/or an incomplete knife cut.This may result in leakage.Ensure the handle is fully squeezed when the metal underside of the handle contacts the stapler body to the fullest extent.When firing the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle contacts the stapler body to the fullest extent.Partial or incomplete handle squeezes may result in unacceptable staple formation and/or incomplete knife cut.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.
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.
Event or Problem Description
According to the reporter, during a laparoscopic lower anterior resection, when end to end anastomosis was performed, the surgeon forced the safety away from the stapler.It was unknown if the surgeon saw green in the indicator window.The safety would not release so the surgeon forced the safety away and fired the circular stapler which caused the misfire.As a result, there was a poor staple formation, incomplete staple line, the donut was poorly formed, staples fell into the cavity of the patient, and the anastomotic site was torn.The surgeon removed the staples with a grasper and suction.The procedure was converted to open, and the surgeon had to re-transect the colon and divert the patient to an ileostomy.The surgical time was extended 30 minutes or more and extended the patient¿s hospitalization (2 days) due to the device problem.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16761987
• Report Number: 2647580-2023-01590
• Device Sequence Number: 6046947
• Product Code: GDW
• UDI-Device Identifier: 10884521593138
• UDI-Public: 10884521593138
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K172361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2023

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: TRIEEAXL28XT
• Device Catalogue Number: TRIEEAXL28XT
• Device Lot Number: P2A0595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/07/2023; 06/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/24/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female