BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE ACTION PUMPING SYSTEM (SAPS)

    MDR report key: 1052536 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00531
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K870557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO ISSUES THAT COULD BE ASSOCIATED WITH THIS INCIDENT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. THE APRIL 2008 15-MONTH IRRIGATION COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED. A VISUAL INSPECTION OF THE RETURNED SAPS DEVICE FOUND THE THUMB TAB HAD SEPARATED FROM THE PLUNGER SHAFT. THE INSIDE OF THE THUMB TAB IS DEFORMED FROM THE ACTION OF IT SEPARATING FROM THE PLUNGER SHAFT. THE DEFORMATION OF THE THUMB TAB INDICATES THE EXTENT OF FORCE APPLIED TO THE EDGE OF THE THUMB TAB, CAUSING THE THUMB TAB TO TILT AND THE PLUNGER TO PUSH THROUGH THE SIDE OF THE THUMB TAB.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM (SAPS) WAS USED DURING A URETEROSCOPY PROCEDURE IN 2008 (AGE, WEIGHT AND SEX IS UNKNOWN). ACCORDING TO THE COMPLAINANT, WHILE PREPARING THE SAPS DEVICE, BECAUSE IT WAS DIFFICULT TO GET THE FLUID IN, THE NURSE KEPT PUSHING HARD. WHILE PUSHING, THE CAP FLEW OFF AND THE PLUNGER WENT INTO HER HAND HORIZONTALLY, APPROXIMATELY TWO INCHES (LIKE A SPLINTER). THE NURSE WENT TO THE EMERGENCY ROOM AND WAS CHECKED AND THEN RELEASED. THEY TREATED THE INJURY SITE WITH A BAND-AID. NO MEDICATIONS WERE GIVEN AND THE NURSE IS FINE. IT WAS ALSO REPORTED THAT THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE ACTION PUMPING SYSTEM (SAPS) KOD BOSTON SCIENTIFIC CORPORATION M0067201001 11460285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK