BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 6562897 · Received May 12, 2017

    Report

    Report Number
    1316463-2017-00004
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 19, 2017
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    UDI-DI
    00732094143676
    PMA / PMN Number
    K070964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE A LOT NUMBER THEREFORE WELCH ALLYN WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THE SPECULUM. AS THE DEVICE AND PACKAGING WAS DISPOSED OF BY THE USER WE WERE UNABLE TO DETERMINE IF THIS WAS A SINGLE RAIL OR DOUBLE RAIL SPECULUM. FOURTEEN REPRESENTATIVE SAMPLES WERE RETURNED TO WELCH ALLYN FOR EVALUATION. THE SPECULA WERE A MIX OF SINGLE RAIL AND DOUBLE RAIL SPECULA. UPON VISUAL INSPECTION OF ALL 14 RETURNED SPECULA NO DAMAGE WAS OBSERVED. MICROSCOPIC EXAMINATION OF THE SINGLE RAIL SPECULA SHOWED NO DAMAGE OR CRACKING. THE SINGLE RAIL SPECULA WERE LAST MANUFACTURED ON 30 JULY 2014. THE ENHANCED DOUBLE WALL SPECULA DESIGN WAS INTRODUCED IN AUGUST 2014. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    WELCH ALLYN RECEIVED A REPORT STATING, KLEENSPEC 590 SERIES DISPOSABLE VAGINAL SPECULUM BROKE WHILE BEING USED ON A PATIENT DURING A PELVIC EXAM. THE SPECULUM WAS EXAMINED BY THE PHYSICIAN PRIOR TO USE AND NO VISIBLE CRACKS WERE NOTED. THE PHYSICIAN INSERTED THE SPECULUM INTO THE PATIENT'S VAGINA AND IMMEDIATELY UPON OPENING OF THE SPECULUM, THE UPPER BLADE SHATTERED. APPROXIMATELY HALF OF THE LEFT SIDE OF THE UPPER BLADE BROKE OFF OF THE SPECULUM. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S VAGINA. THE PATIENT SUSTAINED AN APPROXIMATE 1 TO 2 CM VAGINAL WALL LACERATION FROM THE SHARP EDGE OF THE BROKEN BLADE. PRESSURE WAS APPLIED AND THE BLEEDING SUBSIDED. THE PATIENT RECOVERED WITHOUT FURTHER TREATMENT OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344885 KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA VAGINAL SPECULA HIB WELCH ALLYN 59001 00732094143676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other