BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2780749 · Received October 10, 2012

    Report

    Report Number
    3005075853-2012-04660
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MOST COMMON WAYS TEAR DROP OR PEAR SHAPE CLIPS ARE FORMED IS WHEN THE CLIP IS POSITIONED WITH THE LOOP PORTION PROXIMAL TO THE JAWS FORMING SURFACE. THERE ARE A FEW WAYS THIS FORMATION CAN HAPPEN: CLIP MISLOADING, IS ONE WHERE SOMETHING RESTRICTS THE CLIP FROM ADVANCING ALL THE WAY FORWARD SO THE TIP OF THE CLIPS ARE UP AGAINST THE CLIP STOPS AT THE DISTAL END OF EACH JAW HALF. MOST COMMON CAUSES ARE NOT PULLING THE FIRING TRIGGER FAR ENOUGH AND/OR SOMETHING RESTRICTING THE CLIP ADVANCEMENT, SUCH AS NOT FULLY RELEASING THE FIRING TRIGGER BETWEEN FIRINGS, SIDE FORCE NOT ALLOWING THE DEVICE JAWS TO FULLY OPEN, RAPID FIRING, ETC. EXCESSIVE BACKWARD /IN-LINE FORCE PUSHING THE CLIP BACK INTO THE JAW THROAT DURING FIRING AND OR AN INCOMPLETE FIRING STROKE. THESE MOST OF THE TIME OCCUR SIMULTANEOUSLY, INTERACTING TO CREATE THE PEAR/ TEAR DROP SHAPED CLIP. THE SIZE OF THE LOOP WILL VARY DEPENDING ON THE HOW FAR BACK THE CLIP IS POSITIONED DURING FORMING AND HOW FAR THE TRIGGER IS PULLED. VISUALIZATION DURING FIRING CAN CAUSE AN UNINTENDED FORCE TO PUSH THE CLIP BACK INTO THE JAWS. IN MOST CASES WE HAVE FOUND THAT THE USER INADVERTENTLY INFLUENCES THE CLIP FORMATION AND THE PEAR /TEAR DROP IS ONE OF THE COMMON MALFORMED SHAPES. CONCLUSION: PHOTOGRAPHIC EVIDENCE WHICH INCLUDES PROPERLY FORMED CLIPS, AND REPLICATION OF THE PEAR/TEAR DROP SHAPED CLIPS. THE SUBJECT CLIP FORMATIONS WERE THE RESULT OF INADVERTENT FORCE PLACED ON THE CLIP SHIFTING IT POSITION BETWEEN THE JAWS DURING THE FIRING STROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE CLIP DID NOT FORM CORRECTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED. THE REP STATED THAT THERE IS NO FURTHER INFORMATION ABOUT THE CASE, HE WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1