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U.S. Department of Health and Human Services

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

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COVIDIEN MFG DC BOULDER SILS PORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number SILSPT5
Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pneumonia (2011); Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: transanal total mesorectal excision (tatme): single-centre early experience in a selected population source: updates in surgery (2019) 71:157¿163 published online: 8 november 2018. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of study performed between january and may 2016, study aimed to evaluate the early surgical results following total mesorectal excision to treat rectal cancer. Twelve patients diagnosed with mid-low rectal adenocarcinoma were evaluated with regards demography, histopathology, peri-operative data and postoperative complications. Intraoperative complications were recorded in one case with the failed mechanical anastomosis which was resolved by placing additional interrupted stitches on the suture line. Five out of twelve patients underwent colo-anal anastomosis, 3 handsewn and 2 stapled. The remaining were stapled colorectal anastomoses. All anastomoses were protected with a de-functioning ileostomy. Eleven out 12 patients had less than 200 ml of intraoperative blood loss. They observed the following early post-operative complications 1 case of urinary retention, 1 of pneumonia, 2 skin infections and 2 post-operative ileus. Transanal total mesorectal excision (tatme): single-centre early experience in a selected population michele de rosa1 · fabio rondelli1 · marcello boni1 · fabio ermili1 · walter bugiantella1 · lorenzo mariani1 · graziano ceccarelli1 · antonio giuliani2.

 
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Brand NameSILS PORT
Type of DeviceLAPAROSCOPE, 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 Key10287784
MDR Text Key199218376
Report Number1717344-2020-00746
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK093372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE,USER FACIL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSILSPT5
Device Catalogue NumberSILSPT5
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2020 Patient Sequence Number: 1
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