BEUDAMED
    FDA Adverse Event Other Summary report: N

    IRIS SCS CVD S/S 4-1/2

    MDR report key: 5305934 · Received September 14, 2004

    Report

    Report Number
    1038548-2004-00024
    Event Type
    Other
    Date Received
    September 14, 2004
    Date of Event
    August 16, 2004
    Report Date
    September 14, 2004
    Manufacturer
    CARDINAL HEALTH (SNOWDEN PENCER)
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE SUBJECT DEVICE FOUND THE DISTAL TIP OF THE SCISSOR INSERT BROKE IN A MANNER CONSISTENT AND WITH AN ASSOCIATED BREAK PATTERN THAT ONE WOULD EXPECT IF THE DEVICE FAILED DURING USE. THIS BREAK PATTERN WAS SUCH THAT IT WOULD HAVE RESULTED FROM LATERAL FORCE APPLICATION DURING CLOSURE OF THE SCISSOR. THE EXAMINATION FURTHER NOTED A SIGNIFICANT CHIP IN THE STAINLESS STEEL IMMEDIATELY PROXIMAL TO THE FAILURE POINT. THIS CHIP HAD SHARP MARGINS WHICH ARE INDICATIVE HARD CONTACT WITH A METALLIC SURFACE/DEVICE. IT IS A PROBABLE GIVEN THE LOCATION (IN IMMEDIATE PROXIMITY TO THE FAILURE POINT) THAT THE FAILURE DURING USE WAS INDUCED BE SOME TYPE OF METAL TO METAL COLLISION PRIOR TO THE FAILURE WHICH FRACTURED THE INSERT. THESE TYPES OF COLLISION USUALLY OCCUR DURING HANDLING AND MAY HAVE BEEN ENCOUNTERED DURING REPROCESSING, SET UP, TRANSPORTATION OR OTHER TYPE OF HANDLING. NO FURTHER DETERMINATION IS POSSIBLE. QUALITY HISTORY RECORD FOR THIS LOT WAS REVIEWED AND FOUND NO INDICATION OF MATERIAL DEFECT. NO CAPA POSSIBLE FAILURE DURING USE WAS A RESULT OF PROBABLE HANDLING EVENT.

    Description of Event or Problem · 1

    TIP BROKE OFF INTO PATIENT, WAS RETRIEVED. THE DEVICE BROKE OFF AT THE INCISION AND WAS IMMEDIATELY PICKED OUT. PER THE CUSTOMER, THERE WAS NO PATIENT INJURY, NO XRAY WAS DONE AND THE PATIENT WAS GIVEN KELFLEX ANTIBIOTIC AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS SCS CVD S/S 4-1/2 NONE HNF CARDINAL HEALTH (SNOWDEN PENCER) 32-0705 778731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other