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U.S. Department of Health and Human Services

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

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DAVIS & GECK CARIBE LTD SILS PORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number SILSPT5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930); Peritonitis (2252); Injury (2348); Blood Loss (2597); No Code Available (3191)
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative

Title: ecspect prospective multicentre registry for single-port laparoscopic colorectal procedures author(s): h. Weiss1, r. Zorron4, k. -h. Vestweber5, b. Vestweber5, l. Boni6, w. Brunner8, c. Sietses9, s. Morales conde10, o. Bulut11, k. Gash12, a. R. Dixon12, c. Mittermair1, a. Klaus2, o. Stanger1, m. Weiss1, a. Muratore7 and t. Hell3, on behalf of the ecspect study group year: 2017 (b)(4). If information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to the literature source, the study was to evaluate the safety and feasibility of single-port colorectal surgery. Consecutive patients undergoing single-port colorectal surgery were enrolled from 11 european centers between march 2010 and march 2014. Some 1769 patients were enrolled, 937 with benign and 832 with malignant conditions. Conversion to open surgery was required in 75 patients. Intraoperative complications were observed in 29 patients which include; bleeding in 13 patients, injury to the urinary tract in 7 patients, enterotomy in 5 patients, and splenectomy (owing to laceration, 1). It was also noted that seven of these patients, the operation was converted to open surgery. Postoperative complications were observed in 224 patients, which were presented by complication grade/classification; an anastomotic leak, diffuse peritonitis with the presence of fecal fluid at reoperation, presence of a local abscess in the vicinity of the anastomosis; or fecal discharge from the drain or wounds.

 
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Brand NameSILS PORT
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10245605
MDR Text Key198387361
Report Number9612501-2020-00968
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK093372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
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 Received07/29/2020
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: 07/08/2020 Patient Sequence Number: 1
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