MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SILS PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SILSPT5TA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Yoshiyuki ishii, hiroki ochiai, hiroyuki sako, masahiko watanabe.Long-term oncological outcome of reduced-port laparoscopic surgery (single-incision plus one port) as a technical option for rectal cancer.Asian journal endoscospic surgery.2023;16.Doi: 10.1111/ases.13222.Pages 687¿694.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.
Event or Problem Description
According to literature source of study performed between 2021 and 2017, to clarify the oncological safety of reduced-port laparoscopic surgery (single-incision plus one port) (rps) for patients with rectal cancer.There were 63 patients selected with clinical stage i-iii (t1-3 and n0-2) rectal cancer who underwent rps of radical anterior resection.The patients without a scheduled ostomy, the device was used in the region of the umbilicus.On the patient with planned diverting ileostomy, the device was used on the right lower abdomen of the umbilicus.Postoperative complications included wound infection in one (b)(4) patient.

• Brand Name: SILS PORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20033173
• Report Number: 9612501-2024-02151
• Device Sequence Number: 3035051
• Product Code: GCJ
• UDI-Device Identifier: 10884521102767
• UDI-Public: 10884521102767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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: SILSPT5TA
• Device Catalogue Number: SILSPT5TA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• 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
• Patient Sex: Unknown