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

Model Number 176625

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

Patient Problems Injury (2348); No Code Available (3191)

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, the surgeon performed laparoscopic cholecystectomy, the large clip was being put onto the cystic duct and cystic artery, the surgeon fired the clips and all looked well.However, the patient had a bile leak after several days.The surgeon fixed the leak and performed the laparoscopic bile leak repair.

• Brand Name: ENDO CLIP
• 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: 8366140
• MDR Text Key: 137000030
• Report Number: 9612501-2019-00331
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2019

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 Model Number: 176625
• Device Catalogue Number: 176625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/25/2019
• 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
• Patient Age: 23 YR