BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3100532 · Received May 8, 2013

    Report

    Report Number
    0001056128-2013-00064
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    GEI
    PMA / PMN Number
    K012625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. A VISUAL EXAMINATION OF THE DEVICE REVEALED EVIDENCE OF CLINICAL USE ON THE DISTAL TIP. THE DEVICE WAS MANUALLY ACTUATED AND THE ROTARY DIAL WAS ROTATED SEVERAL TIMES TO VERIFY THAT THE JAWS ACTUATE AND ROTATE AS INTENDED. THE DEVICE DID NOT EXHIBIT ANY UNACCEPTABLE RESISTANCE/STIFFNESS OR ANOMALOUS NOISE DURING THE MANUAL ACTUATION AND ROTARY DIAL ROTATION. A CUT TEST WAS THEN PERFORMED AND FOUND THAT THE DEVICE PASSED CUT TESTING USING POLYSORB SIZE 1 SUTURE. THIS TEST INCLUDES THREE TEST CUTS USING THE PROXIMAL, MIDDLE, AND DISTAL PORTION OF THE SCISSORS. THE TEST IS PERFORMED WITH THE CURVE OF THE SHEARS FACING AWAY FROM THE SUTURE AND IS THEN REPEATED WITH THE CURVE FACING TOWARD THE SUTURE. THE DEVICE WAS THEN USED TO CUT LIVER IN ORDER TO VERIFY THAT THE DEVICE CUT AS INTENDED AND DOES NOT RIP THE LIVER. THE DEVICE WAS ABLE TO SUCCESSFULLY COMPLETE 3 CONSECUTIVE CLEAN CUTS ON THE LIVER AND DID NOT RIP OR TEAR WHEN CUTTING. SSS'S INSTRUCTIONS FOR USE FOR REPROCESSED LAPAROSCOPE ACCESSORIES (SCISSORS, DISSECTORS, GRASPERS) STATES: "INSTRUMENTS WERE DESIGNED FOR CUTTING SOFT TISSUE. ATTEMPTING TO CUT STAPLES OR CLIPS MAY DAMAGE THE INSTRUMENT." "FOR SCISSOR INSTRUMENTS, CUT ALONG THE DISTAL TWO THIRDS OF THE BLADE LENGTH." THE INSTRUCTIONS FOR USE FOR REPROCESSED ENDOSCOPIC INSTRUMENTS (MODEL 5DCS) STATES: "IF CUTTING OF STAPLES OR CLIPS IS ATTEMPTED, DAMAGE TO THE INSTRUMENT MAY OCCUR." "TO AVOID DAMAGE TO PATIENT, TO OPERATOR OR INSTRUMENT, BECOME FAMILIAR WITH A SPECIFIC INSTRUMENT AND ITS CLAMPING OR CUTTING MECHANISM PRIOR TO EMPLOYING IT IN A SURGICAL PROCEDURE." "CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE AS A RESULT OF EXCESSIVE FORCE." "INSTRUMENTS WERE DESIGNED FOR CUTTING SOFT TISSUE. ATTEMPTING TO CUT STAPLES OR CLIPS MAY DAMAGE THE INSTRUMENT." "CLOSE BLADES OR JAWS BEFORE ATTEMPTING TO WITHDRAW INSTRUMENT THROUGH THE CANNULA. VISUALIZE FULLY TO AVOID TRAPPING TISSUE BETWEEN THE JAWS OF THE INSTRUMENT AND CAUSING INADVERTENT DAMAGE. PULL THE INSTRUMENT STRAIGHT OUT THOUGH THE CANNULA, AVOIDING LATERAL PRESSURE THAT MAY DAMAGE THE WORKING TIP." "SET THE VOLTAGE (POWER) AT THE LOWEST POSSIBLE SETTING THAT PROVIDES THE DESIRED SURGICAL EFFECT." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LAPAROSCOPIC "SCISSOR TIPS WERE RIPPING THE TISSUE INSTEAD OF CUTTING." THE PERIOSTEUM WAS RIPPED AS A RESULT OF THE EVENT. THE DOCTOR SEWED UP THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202078 NA GEI GEI STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 5DCS 2248447

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention