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

Patient Problems Failure to Anastomose (1028); Wound Dehiscence (1154); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: "robot-assisted minimally invasive thoraco-laparoscopic 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 thoraco-laparoscopic 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, patient complications reported include: anastomosis leakage requiring surgical and non-surgical intervention, wound infections, post-operative bleeding, abdominal dehiscence, cardiac and pulmonary complications.

• 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: 8582895
• MDR Text Key: 144157162
• Report Number: 9612501-2019-00915
• 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): Required Intervention; Disability