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

Model Number 176630

Device Problem Entrapment of Device (1212)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy, as clips were being placed on gastric staple line, clip that was fired locked the entire applier on the stomach.The entire device had to be torn away along with the clip.Torn tissue was repaired with suture along staple line and there was tissue loss and tissue damage reported.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• 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 Key: 9120843
• MDR Text Key: 160098332
• Report Number: 9612501-2019-01817
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9F0529Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Date Device Manufactured: 06/04/2019
• 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