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

Model Number	EEA33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Necrosis (1971); Tachycardia (2095); Tissue Breakdown (2681); Unintended Radiation Exposure (4565); High White Blood Cell Count (4594)
Date of Event	03/07/2023
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.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 video laparoscopic rectosigmoidectomy, the posterior portion of the anastomosis had a bleeding, which was resolved via manual suturing and a gas installation test was performed through the anus which confirmed that there was no leak.On the 3rd post-operative day, there was wound dehiscence in the opening of the anastomosis at the intersection of the staple line, an exploratory laparotomy, and a colostomy was made in the descending colon loop.Then 4 days after the initial laparotomy, the patient had fever, tachycardia, and significant abdominal pain.Another exploratory laparotomy, was then performed, which showed evidence of necrosis of the efferent segment of the colon of the loop colostomy, resection of the necrotic segment was then performed and the colorectal anastomosis was undone and terminal colostomy was performed and the rectal stump closure was also performed.The patient's condition progressed to daily fever and leukocytosis.A control total abdomen was performed, tomography was performed with multiple intra-abdominal collections and a new exploratory laparotomy was indicated to heal the cavity.The patient's condition progressed to clinical stability and improvement in the clinical condition, however on the 5th part of the last approach, the patient was presented with a new fever and rectal clister was performed with a iodinated contrast and a small rectal stump fistula with perirectal collection was evident, which was drained by rectal tube.The patient then progressed to a clinically stable condition, and was afebrile post-operatively.The treatment was completed with anti-biotic therapy, improved laboratory test and presenting conditions of medical discharge for continuity of outpatient treatment.

• 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: 18470916
• Report Number: 2647580-2024-00137
• Device Sequence Number: 12361808
• Product Code: GDW
• UDI-Device Identifier: 10884523005561
• UDI-Public: 10884523005561
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: EEA33
• Device Catalogue Number: EEA33
• Device Lot Number: P9H0317KY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Date Device Manufactured: 08/07/2019
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male