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

Model Number 176625

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during robotic laparoscopic cholecystectomy procedure, clips fired form the device malformed and fell into the cavity of the patient.The malformed clips needed to be removed from the cystic duct while trying to perform the cholangiogram.At the first two attempts to clip the cholangiogram catheter with the clips did not appear to hold.The clips were removed and attempted dry clipping on a towel outside of the patient.The dry run of the clips showed to form and hold well so the clip applier was reinserted for another clip application.After loading the clip by pulling the trigger, the loaded clip was placed around the duct with catheter and squeezed the handle.The handle would not squeeze easily and after applying two handed force broke the handle leaving the clip jammed in the jaws of the clip applier.Surgeon requested another clip applier to be opened to continue the application.The dry run of clips was practiced again on a towel outside of the patient to ensure this new handle was working correctly.Once it was determined that the clip application was working, the clip applier was inserted through 12mm trocar, pulled the trigger to load a clip and placed it around the cystic duct and squeezed the handle to fire the clip.The clip engaged but another clip was needed to sufficiently hold.Upon loading another clip and placing it around the duct/catheter the handle broke again and the loaded clip was jammed in the jaws.Surgeon instructed to open a new clip applier.It was inserted through the trocar, placed it around the catheter and fired two clips without issue and the procedure was completed.

• 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: 8688220
• MDR Text Key: 147636499
• Report Number: 9612501-2019-01117
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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
• Date Manufacturer Received: 05/22/2019
• 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: 56 YR