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

Model Number SILSPT12

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

Patient Problem Hematoma (1884)

Event Date 05/15/2015

Event Type  Injury  

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 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10263392
• MDR Text Key: 198493380
• Report Number: 1717344-2020-00719
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523002645
• UDI-Public: 10884523002645
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SILSPT12
• Device Catalogue Number: SILSPT12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• 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: 61 YR