BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3093513 · Received May 6, 2013

    Report

    Report Number
    3005075853-2013-02131
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -- CYSTIC ARTERY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -- NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? -- NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? -- NO. WERE ANY UNEXPECTED NOISES HEARD? -- NO. IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- YES. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? THE. INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE JAW BROKEN. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. DUE TO THE RETURNED CONDITION OF THE DEVICE NO FUNCTIONAL TEST COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. ALTHOUGH THE RETURNED CONDITION OF THE DEVICE PREVENTED FUNCTIONAL TESTING TO EVALUATE THE REPORTED INCIDENT, THE LOCKOUT MECHANISM WAS IN A CONDITION THAT PERMITTED FURTHER EVALUATION. DURING THIS TESTING, THE DEVICE LOCKED OUT AS INTENDED. HOWEVER, THE ORANGE INDICATOR DID NOT SHOW UP. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE LEFT LEG OF THE 7TH CLIP WAS INCURVED AT FEEDING INTO THE JAWS AND IT FELL INTO THE PATIENT. THE FALLEN CLIP WAS REMOVED WITH A FORCEPS. AT THE 8TH FIRING, THE JAWS COULD NOT BE OPENED AT FEEDING AND THE DEVICE WAS LOCKED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. DURING WASHING THE DEVICE, IT WAS FOUND THAT A METAL PIECE OF ONE SIDE OF THE JAWS WAS MISSING. DEPENDING ON THE PROCEDURE VIDEO, IT WAS CONFIRMED THAT THE JAWS HAD NOT BEEN DAMAGED DURING THE PROCEDURE. THE OPERATION STAFFS, THE MANAGER OF ANESTHESIOLOGY DEPARTMENT AND THE SURGEON CONSIDERED THAT THE METAL PIECE HAD FALLEN OUT OUTSIDE THE PATIENT AND NO PIECE HAD BEEN LEFT INSIDE THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. AFTER THE OPERATION, THE DEVICE WAS CHECKED OUTSIDE THE PATIENT AND ALL REMAINING CLIPS WERE FIRED AND THEY EJECTED. THE SALES REP CONFIRMED ON THE PROCEDURE VIDEO THAT THE DEVICE HAD NOT BEEN FIRED ACROSS SOMETHING HARD SUCH AS A CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197483 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 FORCEPS