BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24FR 90? CUTTING LOOP ELECTRODE , .012 (6BX)

    MDR report key: 2860170 · Received November 1, 2012

    Report

    Report Number
    2936485-2012-00538
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HIH
    PMA / PMN Number
    K040390
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A QUANTITY OF TWO UNITS WERE IMPLICATED IN THIS EVENT, PLEASE REFER TO MEDWATCH REPORT NUMBER 2936485-2012-00537 FOR UNIT NUMBER 1. ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE LOOP BROKE OFF. IT WAS FURTHER REPORTED THAT THE TIPS DID NOT BREAK OFF IN THE PATIENT. A REPLACEMENT WAS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 24FR 90? CUTTING LOOP ELECTRODE , .012 (6BX) HIH STRYKER ENDOSCOPY 31502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK