BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN V. MUELLER DEVICE

    MDR report key: 4624061 · Received March 23, 2015

    Report

    Report Number
    1038548-2015-00058
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    February 16, 2015
    Report Date
    May 27, 2015
    Manufacturer
    CAREFUSION
    Product Code
    GEI
    PMA / PMN Number
    K030890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER STATED "ITEM WAS EITHER 89-5103 OR 89-5303 WHICH FELL OFF INTO THE PATIENT. THE OPERATING ROOM HAS HAD A COUPLE SCISSOR TIPS TO FALL OFF INTO PATIENTS AND WAS NOT SURE WHICH ONE WAS FOR THIS EVENT. THE SALES REP REPORTED THE CUSTOMER SAID THEY TESTED THE SCISSOR PRIOR TO GIVING IT TO THE SURGEON. THEY DID NOT KEEP THE ITEM. AS THE CUSTOMER REPORTED THE ITEM WAS NOT KEPT A PHOTOGRAPH OR A LOT NUMBER WAS ALSO NOT PROVIDED BY THE CUSTOMER; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. ADDITIONAL INFORMATION RECEIVED 21APR2015: THE SALES REP REPORTED THE HANDLE BEING USED DURING THE REPORTED FAILURE WAS (B)(4). THIS IS THE CORRECT HANDLE TO USE IF THE CUSTOMER ATTACHED EITHER AN 89-5103 OR 89-5303 SCISSOR TIP PRODUCTS. SINCE NEITHER THE SCISSOR TIP PRODUCT OR THE HANDLE UTILIZED WHEN FAILURE OCCURRED WAS RETURNED IT IS UNKNOWN EXACTLY HOW THE FAILURE OCCURRED. THE SALES REP SUSPECTED USER ERROR. AS IT WAS REPORTED THE CUSTOMER TESTED THE SCISSOR PRIOR TO GIVING IT TO THE SURGEON, MOST PROBABLE WHAT OCCURRED IS THE SCISSOR TIP WAS INSTALLED IMPROPERLY AND ULTIMATELY FELL INTO THE PATIENT WHEN ACTUATED. SINCE THE SALES REP SUSPECTED USER ERROR, AN IN-SERVICE WAS CONDUCTED 03MAR2015 ON PROPER ASSEMBLY OF THE SCISSOR TIPS TO ELIMINATE THE POSSIBILITY OF IMPROPER ASSEMBLY. CAREFUSION WILL CONTINUE TO TREND AND MONITOR FOR THIS REPORTED FAILURE.

    Description of Event or Problem · 1

    CUSTOMER STATED THE OPERATING ROOM HAS HAD A COUPLE SCISSOR TIPS TO FALL OFF INTO PATIENTS. THE ITEM IS EITHER 89-5103 OR 89-5303. PATIENT HARM UNKNOWN. ADDITIONAL INFORMATION RECEIVED (B)(6) 2015: THE CUSTOMER REPORTED NO ADDITIONAL INFORMATION. THE SALES REP REPORTED THE CUSTOMER SAID THEY TESTED THE SCISSOR PRIOR TO GIVING IT TO THE SURGEON, THEY DID NOT KEEP THE ITEM, AND THE EVENT OCCURRED ON THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194321 UNKNOWN V. MUELLER DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION UNK - V. MUELLER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other