BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILTEX LASER COATED SPECULUM

    MDR report key: 6529802 · Received April 25, 2017

    Report

    Report Number
    MW5069412
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 25, 2017
    Manufacturer
    MILTEX / INTEGRA
    Product Code
    HDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN EXAM UNDER ANESTHESIA, LOOP ELECTROSURGICAL EXCISION PROCEDURE FOR SEVERE CERVICAL DYSPLASIA. ALTHOUGH THE LASER COATED SPECULUM WAS INSPECTED PRIOR TO USE, IT WAS NOT NOTED THAT IN THE AREA WHERE THE SUCTION TUBE ATTACHES TO THE PHALANGE OF THE SPECULUM THAT THERE WAS SEPARATION FROM THE PHALANGE AND THE LASER COATING HAD FLAKED AWAY. AT THE END OF PROCEDURE, STAFF NOTED THE PT SUSTAINED 2 SUPERFICIAL VAGINAL BURNS (AT 3 O'CLOCK AND 9 O'CLOCK) WHICH ALIGN WITH WHERE THE COATING HAD BEEN COMPROMISED. THIS PROCEDURE WAS DONE WITH MONOPOLAR CAUTERY. PER OPERATING ROOM STAFF REPORTS, PT WAS PROPERLY GROUNDED. WE ARE SEEKING TO MAKE THE MFR AWARE OF THIS POTENTIAL COATING BREAKDOWN AS IT IS IN A DIFFICULT PLACE TO SEE IF YOU'RE NOT EXPECTING TO FIND IT. LEEP PROCEDURE 2/2 SEVER CERVICAL DYSPLASIA. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302433 MILTEX LASER COATED SPECULUM LASER COATED SPECULUM HDG MILTEX / INTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR