BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK

    MDR report key: 6642643 · Received June 15, 2017

    Report

    Report Number
    9611112-2017-00004
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    April 7, 2017
    Report Date
    June 15, 2017
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    GAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. SINCE THE DEVICE WAS RETURNED INCOMPLETE, I.E., WITHOUT THE BROKEN-OFF TIP, IT IS NOT POSSIBLE TO REACH A DEFINITE CONCLUSION WITH REGARD TO THE CAUSE OF THE FRACTURE. HOWEVER, THIS TYPE OF HOOK HAS A VERY DELICATE TIP RANGING FROM 0.5MM TO 1.0MM IN WIDTH DUE TO THE NATURAL ANATOMICAL REQUIREMENTS OF THE VEIN-STRIPPING PROCEDURE, AND THE TIP MAY FRACTURE IF EXCESSIVE PRESSURE IS APPLIED BY THE SURGEON. THUS THE DEVICE MOST LIKELY WAS NOT USED IN ACCORDANCE WITH RECOGNIZED BEST PRACTICES. A REVIEW OF COMPLAINT HISTORY FOR THIS DEVICE FOR THE LAST THREE YEARS REVEALED NO SIMILAR CASES.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DEVICE TIP BROKE OFF DURING A VEIN LIGATION AND STRIPPING ON LEFT LEG. TIP RETRIEVED, NO PATIENT HARM. DEVICE #3 OF 3 USED DURING SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424897 MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK PHLEBECTOMY HOOK GAI HEBUMEDICAL GMBH 31021706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention