MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLOSE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hernia (2240); Stenosis (2263)

Event Date 10/09/2021

Event Type  Injury  

Event Description

According to literature source of study aimed to investigate early safety and effectiveness outcomes of sleeve gastrectomy with transit bipartition that was performed between december 2015 and december 2019, 883 patients participated and postoperative complications included bleeding, gastro-ileal anastomotic stenosis and port-site hernia.Bleeding and hernia required reoperation for treatment.Stenosis required balloon dilatation or reoperation.

Manufacturer Narrative

Title: sleeve gastrectomy with transit bipartition in a series of 883 patients with mild obesity: early effectiveness and safety outcomes source: surgical endoscopy (2022) 36:2631¿2642 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 Description

According to literature source of study aimed to investigate early safety and effectiveness outcomes of sleeve gastrectomy with transit bipartition that was performed between december 2015 and december 2019 wherein (b)(4)patients participated, the gastroileal anastomosis was constructed with a 45-mm tri-staple reload at the antrum, 2 cm from the pylorus.The anastomosis was 35 mm in length as calibrated using the 3-mm width of this stapler.To perform the ileo-jejunostomy to create the common channel, a 60-mm white cartridge was used.Port sites greater than 10-mm wide were closed using trocar closure device with a competitor suture.Postoperative complications included bleeding, gastro-ileal anastomotic stenosis and port-site hernia.Bleeding and hernia required reoperation for treatment.Stenosis required balloon dilatation or reoperation.

Manufacturer Narrative

D10 concomitant product: unknown stapling device (lot number: unknown) additional information: b5, d10, g1, g2, g3 published date: 20 october 2021 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 CLOSE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 14879694
• MDR Text Key: 295107299
• Report Number: 2647580-2022-02250
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521051492
• UDI-Public: 10884521051492
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K954853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173022
• Device Catalogue Number: 173022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN ENDO GIA SULU (LOT NUMBER: UNKNOWN)
• Patient Outcome(s): Required Intervention