BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 6082331 · Received November 7, 2016

    Report

    Report Number
    3005099803-2016-03383
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT AN ATTEMPT TO OPEN THE POUCH WAS PERFORMED LEADING UP TO THE SEAL. THE POUCH WAS STILL SEALED AND STERILITY WAS NOT COMPROMISED. THE EVALUATION REVEALED THAT STERILITY WAS NOT COMPROMISED. DURING MANUFACTURING, DEVICES WERE INSPECTED TO ENSURE THAT ALL FINISHED DEVICES MEET SPECIFICATIONS. MOST LIKELY, THE USER IS DISSATISFIED WITH THE FUNCTION, PERFORMANCE, OR APPEARANCE OF THE PRODUCT. THEREFORE, THE ROOT CAUSE IS USER PREFERENCE ISSUE. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING OF AN ESCAPE¿ STONE RETRIEVAL BASKET, THE DEVICE'S INNER PACKAGE WAS SLIT THROUGH. IT IS UNKNOWN IF THE STERILITY OF THE PACKAGE WAS COMPROMISED. REPORTEDLY, THE BROWN LINING INSIDE THE SHIPPING BOX WAS DISPLACED TO THE SIDE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING OF AN ESCAPE STONE RETRIEVAL BASKET, THE DEVICE'S INNER PACKAGE WAS SLIT THROUGH. IT IS UNKNOWN IF THE STERILITY OF THE PACKAGE WAS COMPROMISED. REPORTEDLY, THE BROWN LINING INSIDE THE SHIPPING BOX WAS DISPLACED TO THE SIDE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734622 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 19722188

    Patients

    Seq Age Sex Outcome Treatment
    1