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

Model Number	EEAXL2535
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
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 colorectal procedure, the device was ultimately unable to be loaded.It was noted that sizers were used.A different anvil was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: d9 (return date), d10, g3, h3, h6 d10 concomitant product: eeaorvil25a eea orvil 25mm automaticdv (lot#: n1l0377y) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the anvil could not be attached.This product was forwarded to ponce engineering for further evaluation of this condition.During analysis, anvil was not able to be attached to instrument retainer.They could not fit together.Further evaluation of the inside area of the center rod identified an obstruction trapped.The inside area was compared to a good representative one, and the obstruction is confirmed.The obstruction or piece could be taken out of the anvil, and it was confirmed to be part of the white trocar tip blunt or sharp.The whole ¿leg¿ for engagement where post was identified.Several traces or damages as a potential misuse or improper engagement to anvil were identified.The material from tip was observed scratched when compared to a representative.It was reported that the anvil was difficult to attach.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: clear instructions for the proper use, engagement and disengagement of the trocars during clinical procedure.Instructions for use of the closed lumen technique includes ¿if the sharp tip (only applicable to 21mm and 25mm staplers) is desired, remove the blunt tip by pressing the black release button and pulling the anvil trocar tip accessory out of the anvil/center rod assembly.Attach the sharp white anvil trocar tip accessory to the hollow shaft on the tilt-top¿ anvil/center rod assembly.The anvil trocar tip accessory will lock into place.The blunt anvil trocar tip accessory is pre-installed on 21mm and 25mm staplers.If the blunt tip is desired for 28mm, 31mm and 33mm staplers, attach the blunt white anvil trocar tip accessory to the hollow shaft on the tilt-top¿ anvil/center rod assembly.The anvil trocar tip accessory will lock into place.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18898485
• Report Number: 2647580-2024-01238
• Device Sequence Number: 12324344
• Product Code: GAG
• UDI-Device Identifier: 10884523006124
• UDI-Public: 10884523006124
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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 Model Number: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Device Lot Number: P2K0161
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 06/05/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/22/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Patient Sex: Unknown