BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLADE CVD METZ SCISSORS TIP 10/EA

    MDR report key: 4187843 · Received October 21, 2014

    Report

    Report Number
    1038548-2014-00046
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 14, 2014
    Report Date
    December 21, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GEI
    PMA / PMN Number
    K030890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CFN-(B)(4):NOTE THAT THE ACTUAL COMPLAINT PRODUCT (B)(4) (SWITCH-BLADE¿ CURVED METZENBAUM CLICK-FIT¿ SCISSOR TIP) WAS NOT RETURNED TO CAREFUSION. TWENTY-ONE (21) OF THE INSTRUMENTS (SP90-1050 - SWITCH-BLADE¿ REUSABLE HANDLE AND SHAFT 5MM, 32CM, INSULATED HANDLE) THE CUSTOMER HAD USED TO MATE WITH THE INSTRUMENT WERE RETURNED FOR EVALUATION. THE CUSTOMER STATED THEY USED A SWITCHBLADE 3.0 SCISSOR TIP (89-5103) THAT IS COMPATIBLE WITH DIFFERENT HANDLES THAN WHAT WAS RETURNED. THE CUSTOMER WAS UTILIZING A SCISSOR TIP THAT IS NOT COMPATIBLE WITH THE SP90-1050 SWITCHBLADE 1.0 HANDLE/SHAFTS THAT WERE RETURNED. THE IFU STATES TO UTILIZE THE FOLLOWING BLADES 89-5100B, 89-5105B, 89-5200B, AND 89-5300B. THESE ARE SWITCH BLADE 1.0 SCISSOR TIPS. THE COMPLAINT SCISSOR TIP WAS SWITCH BLADE 3.0 WHICH CONNECTS TO THE SHAFT VIA A DIFFERENT MECHANISM (CLICK VERSUS SCREW/TWIST) AND REQUIRES USE WITH SWITCHBLADE 3.0 HANDLES SP90-1053 OR SP90-1253. REFERENCE (B)(4). ALL OF THE 21 RETURNED SWITCH-BLADE 1.0 HANDLE/SHAFTS WERE FUNCTION TESTED AND FOUND TO BE FUNCTIONING APPROPRIATELY AND RETAINING THE APPROPRIATE SWITCHBLADE 1.0 SCISSOR TIP. THE FAILURE WAS CONFIRMED THAT THE INCOMPATIBLE PARTS ARE NOT CAPABLE OF BEING ASSEMBLED IN WHICH THE SWITCHBLADE 3.0 SCISSOR TIP WOULD BE RETAINED ON THE SWITCHBLADE 1.0 HANDLE.

    Additional Manufacturer Narrative · 1

    (B)(4)-SHOULD THE DEVICE BECOME AVAILABLE, A FOLLOW-UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER MEDWATCH (B)(4) RECEIVED ON 22SEP2014 INVOLVING AN 89-5103, LOT NUMBER 863806. IT WAS REPORTED THAT (B)(6) YEAR OLD FEMALE PATIENT WEIGHING (B)(6) WAS UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY (B)(6) 2014 AND THE "SCISSOR TIP FELL OFF FROM THE LAPAROSCOPIC SCISSOR HANDLE. SCISSOR TIP REMOVED AND NO ADDITIONAL TREATMENT REQUIRED".: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 06OCT2014. IT WAS REPORTED THAT THE SCISSOR TIP FELL OFF INSIDE OF THE PATIENT'S ABDOMINAL CAVITY. IT WAS UNDETERMINED AS TO WHY THE TIP FELL OFF. IT WAS RETRIEVED VIA THE LAPAROSCOPIC GRASPER. THE DEVICE WAS SENT TO A PREZIO DISTRIBUTOR FOR EVALUATION PER THE CUSTOMER. THE CUSTOMER WAS ASKED TO PROVIDE THE PREZIO REP'S NAME OR THE LOCATION TO RETRIEVE THE INSTRUMENT. AWAITING A RESPONSE.: ADDITIONAL INFORMATION RECEIVED FROM THE PREZIO REP 09OCT2014 VIA PHONE CALL. IT WAS REPORTED THAT 10 CAREFUSION HANDLES WOULD BE RETURNED TO OUR TUCKER GEORGIA FACILITY FOR EVALUATION. HOWEVER, THE ONE INVOLVED IN THE INCIDENCE IS NOT KNOWN. THE SCISSOR TIP WAS DISCARDED AND THEREFORE WILL NOT BE SENT IN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668416 SWITCH-BLADE CVD METZ SCISSORS TIP 10/EA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION 89-5103 863806

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other