MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number UNKNOWN ENDO CLIP APPLIER

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problems Failure to Anastomose (1028); Death (1802); Fistula (1862)

Event Date 04/04/2019

Event Type  Death  

Manufacturer Narrative

Title robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer source annals of surgery, volume 269, 2019 (621¿630) article number: 4 date of publication: april 2019 if information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to literature source of study performed a robot-assisted minimally invasive thoracolaparoscopic esophagectomy (ramie) may reduce complications in patients with esophageal cancer.The literature reports on a single-center randomized controlled trial assigning 112 patients with resectable intrathoracic esophageal cancer to either ramie or open transthoracic esophagectomy (ote).It was reported that the procedure requires the use of a clip applier and a linear stapler.The primary endpoint was the occurrence of overall surgery-related postoperative complications post operatively, it was reported in the ramie group 2 patients died in the hospital from mediastinitis after anastomotic leakage and in the ote group 1 patient died in hospital due to a tracheoesophageal fistula.

• Brand Name: UNKNOWN ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• 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: 8582875
• MDR Text Key: 144155601
• Report Number: 9612501-2019-00914
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO CLIP APPLIER
• Device Catalogue Number: UNKNOWN ENDO CLIP APPLIER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• 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; Required Intervention; Disability