BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM

    MDR report key: 3970095 · Received April 28, 2014

    Report

    Report Number
    2916714-2014-00300
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    February 7, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    GCJ
    PMA / PMN Number
    K970949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION IS ON-GOING. WAITING FOR PRODUCT RETURN.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY: DURING A LAPAROSCOPIC GALL BLADDER OPERATION, A PIECE OF THE GRASPER BROKE, AND ALTHOUGH THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE, THE SURGEON WAS ABLE TO LOCATE THE BROKEN PIECE. DOCTOR HAS SAID THE PIECE LEFT IN THE PT SHOULD NOT HARM THE PT; HOWEVER, FACILITY STATES IT REMAINS TO BE SEEN IF THERE WILL BE ANY INJURY BEYOND A FOREIGN OBJECT IN THE BODY. SURGERY TOOK 1.5 HOURS TO COMPLETE DUE TO RESEARCH FOR MISSING PIECE. DR USUALLY COMPLETES THE SURGERY IN HALF AN HOUR, BUT THE SURGERY CAN TAKE UP TO 1.5 HRS TO COMPLETE. OTHER DEVICES WERE USED FOR THE SURGERY AND ANOTHER GRASPER WAS USED TO REPLACE THE BROKEN ONE. SURGERY CONVERTED FROM A LAPAROSCOPIC TO AN OPEN PROCEDURE TO ATTEMPT TO RETRIEVE THE PIECE. THE LOCATION OF THE BREAK IS ON THE DISTAL END OF THE DEVICE, NON MOVABLE JAW. IN ADDITION, X-RAY CONFIRMATION OF RETAINED PIECE WAS INITIATED AT FACILITY. X-RAY CONFIRMED 1.6 CM RETAINED PIECE IN RIGHT UPPER QUADRANT (BEHIND THE KIDNEY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253440 PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM GRASPER GCJ SMITH & NEPHEW ENDOSCOPY 8360-00

    Patients

    Seq Age Sex Outcome Treatment
    1