MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. SILS PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SILSPT12TA

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

Patient Problems Hernia (2240); Post Operative Wound Infection (2446)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown ligasur (unknown ligasure instrument, lot number: unknown).Title: operative outcomes of single-incision laparoscopic hysterectomy vs conventional laparoscopic total hysterectomy: a prospective randomized controlled study source: doi: 10.1177/15533506211041892.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.

Event Description

According to the literature source of aprospective randomized controlled study of operative outcomes of single-incision laparoscopic hysterectomy versus conventional laparoscopic total hysterectomy performed between february 2016 and october 2019, 25 female patients underwent through single-incision laparoscopic hysterectomy (silh).Post-operative morbidity include a port-site infection and port-site hernia.

• Brand Name: SILS PORT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer (Section G): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16270760
• MDR Text Key: 308445679
• Report Number: 3003139373-2023-00024
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521102774
• UDI-Public: 10884521102774
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K103253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SILSPT12TA
• Device Catalogue Number: SILSPT12TA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female