BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MCA

    MDR report key: 6613873 · Received June 6, 2017

    Report

    Report Number
    3005075853-2017-02901
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 14, 2017
    Report Date
    May 24, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # K92132. THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE NO DAMAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED, RETAINED AND FORMED THE REMAINING 14 CLIPS AS INTENDED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, NO ANOMALIES WERE FOUND. AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE CLIP FALL OUT OF THE JAWS OF THE DEVICE DURING FIRING? OR WAS THE CLIP FIRED AND DID NOT CLOSE ON THE TISSUE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE SURGEON TRIED TO USE THE DEVICE, BUT WHEN THE TRIGGER WAS PRESSED, THE CLIP CAME OUT OPEN AND DID NOT CLOSE. SEVERAL SHOTS WERE TRIED AND IN NO CASE THE CLIP WAS CLOSED AND THE MEDIC REQUESTED ANOTHER STAPLER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397345 LIGACLIP ENDOSCOPIC ROTATING MCA CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4D859

    Patients

    Seq Age Sex Outcome Treatment
    1