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

Model Number	EEAXL28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robotic closure of a colostomy, the staples fired did not properly stay in the intended staple line, becoming loose inside the patient.The surgeon had to dissect the affected tissue and use a different stapler.
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.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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was received for evaluation with anvil separated.Green indicator was not visible as received and the whole safety feature area was broken off characteristic when handle is squeezed before safety is fully disengaged.Safety latch was not received for evaluation and the handle was disengaged from the internal components.Marks or damages of rough handling are identified where safety latch was assembled as evidence of presence and force to be removed.The body weld was observed to be broken as it could be separated, however, proper welding evidence can be observed along the instrument handle.The staple guide was observed to be attached to the instrument with no damage.Anvil was tilted, and cutting mylar was not transected.Anvil cutting ring showed no traces of knife impression around area circumference.Complaint anvil center rod legs were bent casing deformation of the area after firing.It was reported that the staple line did not hold.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue of the observed anvil damage may occur if the anvil is manipulated with excessive force during the attachment to the instrument, or if the anvil is mishandled during the removal of fitting accessories.The issue of the no knife impression condition 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 issue of the observed safety damage may occur if the latch is forced into disengagement prior to green indicator visibility.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: do not use the instrument with 4.8mm staples on any tissue that will not comfortably compress to 2.0mm in thickness.The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.Do not turn the twist knob more than one (1) turn counterclockwise after firing.Doing so may result in difficulty in removing the device or separation of the anvil assembly.Fully extend the center shaft of the stapler by turning the twist knob counterclockwise until it stops.Mate the anvil/center rod assembly to the stapler by inserting the blunt center rod into the center shaft of the stapler and push firmly until the center rod clicks into its fully seated position.This click will be tactile and audible.Manually inspect the attachment to ensure that the center rod and stapler are fully mated.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.The safety will not release if the green bar is not visible in the indicator window.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: EEA
• Common Device Name: STAPLER, SURGICAL
• 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: 17650258
• Report Number: 2647580-2023-03689
• Device Sequence Number: 7212842
• Product Code: GDW
• UDI-Device Identifier: 10884523006131
• UDI-Public: 10884523006131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: EEAXL28
• Device Catalogue Number: EEAXL28
• Device Lot Number: P9C1338KY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 02/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• 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
• Patient Sex: Unknown