BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT

    MDR report key: 1894207 · Received November 2, 2010

    Report

    Report Number
    2936485-2010-00812
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DOCTOR ATTEMPTED TO RETRACT THE TIP OF THE STRYKEPROBE J-TIP INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE TIP OF THE STRYKEPROBE J-TIP BECAME STUCK INSIDE THE SHEATH, AS IT MAY HAVE BEEN BENT AND BECAME LODGED ON THE EDGE OF THE SHEATH. THE SHEATH CRACKED AND A PORTION OF IT FELL INTO THE PATIENT. THE DOCTOR ATTEMPTED TO LOCATE THE BROKEN PIECE INSIDE THE ABDOMEN OF THE PATIENT AND A NURSE ATTEMPTED TO USE STRAINERS ON THE IRRIGATION FLUID TO TRY AND LOCATE THE BROKEN PIECE INSIDE A SUCTION CANISTER. THE BROKEN PIECE COULD NOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT SHEATH GCJ STRYKER ENDOSCOPY SAN JOSE 073010-03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK