BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK TAKEAPART ML 5MM ENDO APPLIER

    MDR report key: 7699132 · Received July 18, 2018

    Report

    Report Number
    3011137372-2018-00201
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 27, 2018
    Report Date
    June 27, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DHR REVIEW HAS BEEN PERFORMED FOR PRODUCT #544965T, LOT#P1300819. IT CAN BE CONFIRMED THAT THE CORRECT MATERIAL AND THE CORRECT COMPONENTS HAVE BEEN USED AND THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE INSTRUMENT WAS REPAIRED BY K+W DURING OCTOBER 13, AND AT THAT TIME THE INSERT AND SHAFT WERE REPLACED. WE HAVE NOT RECEIVED A SAMPLE FOR A PRODUCT REVIEW, THEREFORE; THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5MM HOL APPLIERS JAWS RUPTURED IN THE PATIENT'S ABDOMEN WHILE APPLYING A HEM-O-LOK CLIP ON THE CYSTIC DUCT. THE CLIP WAS NOT CLOSING AFTER TRYING A COUPLE OF TIMES. THE JAWS COLLAPSE AND A SMALL METAL PART THAT LOOKED LIKE A VERY SMALL SCREW OF THE APPLIER CAME OFF IN TO THE PATIENT'S ABDOMEN AND WAS REMOVED. AN X-RAY WAS PERFORMED TO SEE IF ANY OTHER METAL PARTS WERE IN THE PATIENT'S ABDOMEN; NONE WERE FOUND. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5MM HOL APPLIERS JAWS RUPTURED IN THE PATIENT'S ABDOMEN WHILE APPLYING A HEM-O-LOK CLIP ON THE CYSTIC DUCT. THE CLIP WAS NOT CLOSING AFTER TRYING A COUPLE OF TIMES. THE JAWS COLLAPSE AND A SMALL METAL PART THAT LOOKED LIKE A VERY SMALL SCREW OF THE APPLIER CAME OFF IN TO THE PATIENT'S ABDOMEN AND WAS REMOVED. AN X-RAY WAS PERFORMED TO SEE IF ANY OTHER METAL PARTS WERE IN THE PATIENT'S ABDOMEN; NONE WERE FOUND. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542524 HEMOLOK TAKEAPART ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL P1300819

    Patients

    Seq Age Sex Outcome Treatment
    1