MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK; Laparoscope, general & plastic surgery

Model Number UNKNOWN PROTACK

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

Patient Problems Hematoma (1884); Pain (1994); Seroma (2069)

Event Date 05/28/2022

Event Type  Injury  

Event Description

According to the literature source of study performed between december 2013 and january 2016, a prospective study analyzed postoperative outcomes after primary closure of defect in patients who underwent laparoscopic ventral hernia repair (lpvh) with primary closure of defect (pcd) using a running suture and intraperitoneal mesh placement, at 5-year follow-up.There were a total of 60 patients in the study.Closure of the hernia defect was performed using a fully intracorporeal continuous suture with a long-term absorbable double-loop suture in polyglyconate, monoflament absorbable suture with the use of endo close or a competitor device.A competitor mesh was placed and fixed using a tacker.Post operative complications included hernia recurrence, seroma, hematoma and chronic pain.Computed tomography (ct) scan was performed at 60 months in case of suspicion for recurrence or bulging at physical examination.Hematomas were treated conservatively.Chronic pain was treated with conventional analgesics. .

Manufacturer Narrative

Title: primary closure of the midline abdominal wall defect during laparoscopic ventral hernia repair: analysis of risk factors for failure and outcomes at 5 years follow-up.Source: surgical endoscopy (2022) 36:9064¿9071.Https://doi.Org/10.1007/s00464-022-09374-9.Received: 2 january 2022 / accepted: 28 may 2022 / published online: 21 june 2022 ©.The author(s), under exclusive licence to springer science+business media, llc, part of springer nature 2022 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.

• Brand Name: UNKNOWN PROTACK
• 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: 16104480
• MDR Text Key: 306732804
• Report Number: 2647580-2023-00063
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2022
• 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 - MAXON (LOT#UNKNOWN).
• Patient Outcome(s): Required Intervention