MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SILS PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SILSPT12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: international journal of surgery: single incision laparoscopic resection for diverticulitis source: international journal of surgery 19 (2015) 11-14, http://dx.Doi.Org/10.1016/j.Ijsu.2015.05.012.1743-9191/© 2015 ijs publishing group limited.Published by elsevier ltd.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study performed in between october 2009 and august 2013, the study aims to determine effectiveness of single incision laparoscopic surgery as a minimally invasive surgery for patient with recurrent diverticular disease.The patients list is a total of 488 consecutive patients treated by sigmoidectomy by single incision laparoscopic surgery.Post-operatively there were three patients with minor complications which is subcutaneous hematomas.

• Brand Name: SILS PORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10263392
• Report Number: 1717344-2020-00719
• Device Sequence Number: 11338175
• Product Code: GCJ
• UDI-Device Identifier: 10884523002645
• UDI-Public: 10884523002645
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SILSPT12
• Device Catalogue Number: SILSPT12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR