BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOGEN CLAMP

    MDR report key: 2393073 · Received March 5, 2007

    Report

    Report Number
    2431166-2007-00008
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    December 2, 2006
    Report Date
    March 14, 2007
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    HFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UNTIL THE DEVICE IS RETURNED AND EVALUATED; IT CANNOT BE 100% DETERMINED THAT THE DEVICE IS THE ONE WE MANUFACTURED AND SOLD TO THE HOSPITAL. HOWEVER, THE PHOTOCOPY TAKEN OF THE DEVICE INDICATES WITH A HIGH DEGREE OF CERTAINTY THAT THE REPORTED DEVICE WAS NOT MADE BY SKLAR FOR THE FOLLOWING REASONS: WE DO NOT ETCH INFO ON THE EDGE OF OUR INSTRUMENT. THE INSTRUMENT IN THE PICTURE SHOWS "MOGEN" ETCHED ON THE INSTRUMENT, SOMETHING WE WOULD NOT PUT ON A SKLAR INSTRUMENT. THE DEVICE IN THE PICTURE SHOWS (B)(4) WHICH IMPLIES A PRODUCT MADE IN (B)(4) OR A DEVICE MADE OF (B)(4) STEEL. WE USE AN AMERICAN SUPPLIER. THE DEVICE IS CODED WITH A MARKING NOT ASSOCIATED WITH OUR METHOD OF CODE MARKING. OUR CLAMP HAS A PATENT "LOCKING MECHANISM" THAT ENSURES THAT THE MECHANICAL MOVEMENT OBSERVED BY THE PHYSICIAN DOES NOT OCCUR. NONETHELESS, IT IS SUSPECTED THAT THE DEVICE DESCRIBED AND RESULTING INJURY OCCURRED BECAUSE IT WAS NOT INSPECTED PRIOR TO USE TO ENSURE THAT: THE JAW GAP DIMENSIONS ARE ADEQUATE FOR INTENDED USE. THE CLAMP CHOSEN IS APPROPRIATELY SIZED FOR THE PT.

    Description of Event or Problem · 1

    SKLAR INSTRUMENTS REC'D THE EVENT THAT IS DESCRIBED BELOW IN THE MAIL ON 3/5/2007. THE INITIAL RPTR, THE DIRECTOR OF RISK MANAGEMENT FOR THE HOSPITAL, STATES THAT THE MOGEN CLAMP WAS APPLIED BY THE PHYSICIAN TO THE PT'S PENIS, AND CIRCUMCISION WAS PERFORMED IN THE USUAL AND STANDARD MANNER. FOLLOWING THE CIRCUMCISION, THE SKIN WAS PULLED BACK AND BLEEDING WAS NOTED. UPON FURTHER INSPECTION OF THE REMOVED FORESKIN, THE PHYSICIAN NOTED AN AMPUTATION OF THE DISTAL END OF THE GLANS PENIS MEASURING APPROX 10 MM IN DIAMETER. A UROLOGIST AND A PLASTIC SURGEON WERE CONSULTED RELATIVE TO THE AMPUTATED PORTION OF THE GLANS PENIS. THE BLADDER WAS DRAINED OF URINE. A PROCEDURE WAS PERFORMED AND THE AMPUTATED PORTION OF THE GLANS PENIS WAS REATTACHED TO THE PENIS. THE REATTACHMENT PROCEDURE WAS SUCCESSFUL; HOWEVER, FOLLOWING THE PROCEDURE, THE PT'S STREAM OF URINE WAS NOTED TO BE AT A SIDE ANGLE. FOLLOWING THE INJURY, THE PHYSICIAN INSPECTED THE MOGEN CLAMP AND FOUND IT TO BE LOOSE WITH LATERAL MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOGEN CLAMP HFX SKLAR INSTRUMENTS NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention| S