BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARADY PHLEBECTOMY EXTRACTOR, 6-3/4 SM HOOK

    MDR report key: 7337847 · Received March 14, 2018

    Report

    Report Number
    9611112-2018-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    December 21, 2017
    Report Date
    March 14, 2018
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    GAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. IT HAD BEEN MANUFACTURED IN NOVEMBER 2014. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO MICROSCOPIC EXAMINATION. IT SHOWED NO EVIDENCE OF EXTENSIVE REUSE. 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 EXTRACTOR HAS A VERY DELICATE HOOK TIP DUE TO THE NATURAL ANATOMICAL REQUIREMENTS OF THE VEIN-STRIPPING PROCEDURE, AND THE TIP MAY FRACTURE IF EXCESSIVE PRESSURE IS APPLIED BY THE SURGEON.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE HOOK OF THE VARADY PHLEBECTOMY EXTRACTOR BROKE OFF AND WAS STUCK INSIDE THE EXTRACTED VEIN. NO PATIENT INJURY NOR DELAY OCCURRED NOR WERE ANY REVISIONS OR MEDICAL INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180306 VARADY PHLEBECTOMY EXTRACTOR, 6-3/4 SM HOOK EXTRACTOR GAI HEBUMEDICAL GMBH 100088-1411

    Patients

    Seq Age Sex Outcome Treatment
    1