MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

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

Patient Problems Death (1802); Fistula (1862); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 04/23/2014

Event Type  Death  

Manufacturer Narrative

Title minimally invasive oesophagectomy: preliminary results after introduction of an intrathoracic anastomosis source digestive surgical, 2014 (95-103) date of publication: 23 april 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from january 2011 until august 2012, a total of 45 operable patients were scheduled to undergo minimally invasive esophagectomy (mie) with intrathoracic anastomosis.Eighteen out of the 45 patients were under group 2 wherein a circular stapler was used to create an intrathoracic anastomosis along with its anvil being inserted through one of the ports and secured with 2 purse strings using the stitching device and suture.One of the patient's post-operative course complicated by chyle leakage, and this was managed conservatively with total parenteral feeding during 6 days.A contrast swallow ct scan 4 days post-operatively showed no signs of anastomotic leakage.The patient died 25 days after surgery of massive hemorrhage from a gastro-aortic fistula at the level of the anastomosis requiring emergency surgery.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8432902
• MDR Text Key: 139212444
• Report Number: 9612501-2019-00549
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• 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): Death
• Patient Age: 66 YR