BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 1901478 · Received November 12, 2010

    Report

    Report Number
    2648666-2010-00451
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE MOST LIKELY ROOT CAUSES OF THE REPORTED FAILURE INCLUDE THE FOLLOWING: EXCESSIVE FORCE APPLIED BY THE USER; SHAVER BLADE CAME INTO CONTACT WITH A METAL OBJECT DURING USE; MATERIAL STRENGTH. THE IFU FOR THE PRODUCT WARNS AGAINST THE USE OF EXCESSIVE FORCE AND ALSO WARNS AGAINST ALLOWING CONTACTS TO BE MADE BETWEEN THE SHAVER BLADES AND METAL OBJECTS DURING USE. IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE UNIT BROKE OFF DURING A CASE AND REMAINED IN THE PT FOR ROUGHLY 7 MONTHS. IT WAS FURTHER REPORTED THAT REVISION SURGERY WAS PERFORMED ON THE PT AND THE BROKEN PIECE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other