BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNIFE

    MDR report key: 2116698 · Received May 20, 2011

    Report

    Report Number
    2523835-2011-00062
    Event Type
    Other
    Date Received
    May 20, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. BECAUSE THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNK, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. THERE HAVE BEEN NO CHANGES IN THE MFG PROCESS THAT WOULD CONTRIBUTE TO DAMAGED BLADES. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MFG. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE QUALITY OF THE BLADES WERE NOT "CONSTANT" AND THAT IT HAS BEEN NOTICED REGULARLY THAT THE BLADES ARE LESS SHARP. ADDITIONAL INFO WAS RECEIVED INDICATING THE SURGEON, OFTEN TIMES, USES SUTURES IN A CERTAIN NUMBER OF CASES. MULTIPLE PROCEDURES WERE REPORTED WHERE SUTURES WERE NECESSARY. HOWEVER, THE SURGEON WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFO, SUCH AS PT IDENTIFIERS, AS HE DID NOT WANT TO FILE A COMPLAINT FOR THERE EVENTS. THERE WERE NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other