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

Model Number 176630

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

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 sigmoidectomy, after clipping several times, the clip became unable to be loaded into the jaws.The surgeon stopped using the device and opened a same new product.When trying to use to use the new one, the clip could not be loaded into the jaws from the beginning.Another same new product was opened again, and the device was able to be used without problems.There was no patient injury.

• 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: 9504759
• MDR Text Key: 181545385
• Report Number: 9612501-2019-02504
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9E1640Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Date Device Manufactured: 05/14/2019
• 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