BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3936091 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04979
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THIS A PLANNED OR EMERGENCY CHOLECYSTECTOMY? WAS THIS A TYPICAL CASE? ARE THE CLIPS IN QUESTION THE CLIPS THAT WERE FIRED ON THE CYSTIC DUCT OR CYSTIC ARTERY? WAS THE DEVICE USED FOR A CHOLANGIOGRAM? WHEN THE CLIP DID NOT DEPLOY ON THE THIRD FIRING, WAS THE CLIP VISIBLE IN THE JAWS PRIOR TO FIRING? OR WAS THE CLIP NOT FED INTO THE JAWS? PLEASE CLARIFY WHAT IS MEANT BY ¿CLIP WAS NOT CLAMPING THE TISSUE¿. WAS THE CLIP PROPERLY FORMED? IF NOT, WHAT WAS THE SHAPE OF THE CLIP? (I.E. SCISSORED, PEAR SHAPE, MALFORMED, ETC.) WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? HOW MANY HOURS OR DAYS DID THE PATIENT RETURN TO THE OPERATING ROOM? WHAT WERE THE PATIENT¿S SYMPTOMS? HOW WAS THE ISSUE IDENTIFIED? HOW WAS THE ISSUE TREATED? IF THE PATIENT REQUIRED A RE-OPERATION, PLEASE EXPLAIN WHAT WAS OBSERVED. WERE CLIPS FOUND ON THE DUCT AND/OR ARTERY? IF SO, WHAT WAS THE SHAPE OF THE CLIPS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ON THE THIRD FIRING THE CLIP DID NOT DEPLOY. ON THE FOURTH FIRING THE CLIP WAS NOT CLAMPING THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. POST-OP THE PROCEDURE, THE PATIENT RETURNED DUE TO THE CLIP NOT HOLDING ON THE TISSUE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413630 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E79A

    Patients

    Seq Age Sex Outcome Treatment
    1