BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4182428 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07208
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    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
    TH
    Reporter Occupation
    OTHER

    Narratives

    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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THERE ARE 5 DEVICES HAVE PROBLEM. EACH DEVICE HAVE 20 CLIPS THAT NOT EVERY CLIP HAVE PROBLEM WHICH DOCTOR HAVE TO APPLY MORE CLIP THAN NORMAL. ADDITIONAL IN ONE CASE CLIP DIDN'T CLOSE PROPERLY DOCTOR TRYING TO APPLY MORE AND MORE TILL CITRIC DUCT CUTTING. CASE COMPLETE BY APPLY CLIP MORE THAN USUAL SOME CLIP ARE OK SOME ARE NOT.

    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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THERE ARE 5 DEVICES HAVE PROBLEM. EACH DEVICE HAVE 20 CLIPS THAT NOT EVERY CLIP HAVE PROBLEM WHICH DOCTOR HAVE TO APPLY MORE CLIP THAN NORMAL. ADDITIONAL IN ONE CASE CLIP DIDN'T CLOSE PROPERLY DOCTOR TRYING TO APPLY MORE AND MORE TILL CITRIC DUCT CUTTING. CASE COMPLETE BY APPLY CLIP MORE THAN USUAL SOME CLIP ARE OK SOME ARE NOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP CANNOT COMPLETELY PINCH THE BLOOD VESSEL. NO ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP CANNOT COMPLETELY PINCH THE BLOOD VESSEL. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661569 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1