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

Model Number 176630

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied.No visual abnormalities were observed with the instrument.The instrument was cycled and the clip did not load, the pusher bar was observed not functioning properly.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The trip lever out of position was preventing the clips from loading properly.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the clips were able to load properly into the jaws, but when the surgeon attempted to fire the first clip it did not fire.The surgeon was not able to squeeze the handle and once the 2nd clip was loaded the jaws locked and the device could not be fired.The surgeon then used another device to resolve the issue in order to complete the case.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 middeltown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9686629
• MDR Text Key: 178347986
• Report Number: 9612501-2020-00242
• 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: Physician
• Type of Report: Initial
• Report Date: 02/10/2020

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: 04/30/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9E1646Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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