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

Model Number 176657

Device Problems Mechanical Problem (1384); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, there were malformed clips.The surgeon was could not squeeze the handle and experienced an issue loading or firing the clips at the time of ligating the cystic duct.Another device was used to complete the case.There was no patient injury.

• Brand Name: ENDO CLIP II
• 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 02048 ; 2034925563
• MDR Report Key: 9505473
• MDR Text Key: 181545487
• Report Number: 9612501-2019-02492
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J6D2009CX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/20/2019
• Date Device Manufactured: 04/19/2016
• 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