BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLADE CLICKFIT REUSE HNDL 5MM36CM

    MDR report key: 2277585 · Received October 5, 2011

    Report

    Report Number
    1038548-2011-00030
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    October 5, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GEI
    PMA / PMN Number
    K030890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR WAS PREVIOUSLY SUBMITTED WITHIN THE 30 DAY TIME FRAME BEARING THE REGISTRATION NUMBER OF CARDINAL HEALTH IN ERROR DUE TO A REPORTING SOFTWARE DISCREPANCY. CAREFUSION HAS BEEN ADVISED BY (B)(4) FDA TO RESUBMIT THE MDR BEARING CAREFUSION'S REGISTRATION NUMBER AND TO INCLUDE THIS VERBIAGE WITHIN THE REPORT, AS WELL AS WITHIN CAREFUSION'S COMPLAINT MANAGEMENT SOFTWARE.' EVALUATION OF THE DEVICE RECEIVED COULD NOT CONFIRM THE REPORTED ISSUE. THE DEVICE RECEIVED WAS RETURNED WITH A TIP THAT WAS NOT COMPATIBLE WITH THE INSTRUMENT. THE TIP RETURNED WAS MEANT FOR A STANDARD FIT (SWITCHBLADE 1 SCISSOR TIP) NOT A CLICKFIT. THE SNOWDEN PENCER SWITCH BLADE CLICKFIT REUSE HAND 5MM 45CM IS INTENDED TO BE USED WITH SNOWDEN PENCER SWITCH BLADE SCISSOR TIPS (89-5103, 89-5303, AND 89-5115). THE SCISSOR TIP RETURNED WOULD NOT THREAD INTO THE INSTRUMENTS SHAFT. THE LOT CODE ETCHED ON THE INSTRUMENT 'K10' INDICATES THIS INSTRUMENT WAS MANUFACTURED IN NOVEMBER 2010. AS A LOT NUMBER WAS NOT PROVIDED AND THE ORIGINAL ORDER COULD NOT BE TRACED, A DHR REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS FUNCTION TESTED AND FOUND TO FUNCTION AS INTENDED WITH USE IN CONJUNCTION WITH THE CORRECT SCISSOR TIPS. THE DEVICE WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT INVOLVEMENT BUT NO INJURY. TIP OF SCISSOR TIP FELL OFF IN PATIENT DURING PROCEDURE. FOLLOW UP CONVERSATION WITH (B)(6), SURGICAL COORDINATOR (B)(6) 2011. (B)(6) PROVIDED MORE DETAILS TO THE EVENT OF "SCISSOR FELL OFF IN PATIENT DURING PROCEDURE." SHE INDICATED THAT THE SURGEON USING THE SCISSOR WAS LEFT HANDED, SHE STATED THE SURGEON DOES A SWEEPING MOTION CUTTING THROUGH FAT AND TISSUE WITH THE SCISSORS. SHE STATED THAT THE SCISSORS CAME APART AT THE SCREWED TOGETHER AREA AND HALF FELL INTO THE PATIENT. SHE STATED THERE WAS NO UNTOWARD EFFECT TO THE PATIENT AND THE SCISSOR HALF WAS RETRIEVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS A SMALL AMOUNT OF ADDITIONAL TIME ADDED TO THE PROCEDURE TO RETRIEVE THE INSTRUMENT. NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCH-BLADE CLICKFIT REUSE HNDL 5MM36CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION SP90-1053 NONE PROVIDED AND COULD NOT BE

    Patients

    Seq Age Sex Outcome Treatment
    1