BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3999651 · Received August 11, 2014

    Report

    Report Number
    0001056128-2014-00089
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    May 25, 2014
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLM
    PMA / PMN Number
    K063788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE REVEALED EVIDENCE OF CLINICAL USE INCLUDING THE PRESENCE OF BIOLOGICAL MATERIAL. THE CANNULA SLEEVE WAS OBSERVED TO BE BROKEN IN PIECES SUBSTANTIATING THE REPORTED ISSUE. THE DEVICE WAS IDENTIFIED AS A POLYESTER MATERIAL. RESULTS OF THE INVESTIGATION CONFIRMED THE REPORTED ISSUE AS THE CANNULA WAS OBSERVED TO BE BROKEN. AS THE DAMAGE OCCURRED DURING WITHDRAWAL AND WAS AT THE DISTAL END OF THE CANNULA, THE MOST LIKELY CAUSE OF THE DAMAGE IS EXCESSIVE LATERAL FORCE DURING WITHDRAWAL. IT IS ALSO POSSIBLE THE CANNULA HAD A CRACK AS A RESULT OF SHIPPING DAMAGE OR INSTRUMENT INSERTION TECHNIQUE WHICH WAS NOT NOTICED DURING THE PROCEDURE AND RESULTED IN A WEAKER MATERIAL INTEGRITY OF THE CANNULA. A REVIEW OF THE LOT CONTROL SHEET (LCS) INDICATED THAT ALL REQUIRED INSPECTIONS AND TESTS WERE CONDUCTED ON ALL DEVICES IN THE LOT IN QUESTION INDICATING THAT THE INSTRUMENT WAS IN WORKING CONDITION WHEN RELEASED FROM STRYKER® SUSTAINABILITY SOLUTIONS. THE INSTRUCTIONS FOR USE REPROCESSED APPLIED MEDICAL ENDOSCOPIC TROCARS AND CANNULAS (IFU) STATES: "PRIOR TO USE, READ AND FOLLOW THE INSTRUCTIONS OF THIS INSERT AS WELL AS THOSE OF THE INSTRUMENTS TO BE USED DURING THE PROCEDURE. DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE." "DO NOT USE EXCESSIVE FORCE." "CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE." "INSPECT THE INSTRUMENTS FOR ANY DAMAGE. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY." THIS REPORT WAS FILED DUE TO SSS BEING IN A TWO YEAR REPORTING CYCLE FOR A TROCAR SHATTERING AND MEDICAL INTERVENTION BEING REQUIRED TO REMOVE THE PIECES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS NOT YET BEEN COMPLETED FOR THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE AN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CASE, "THE 5MM PORT TIP SHATTERED INTO MULTIPLE PIECES." THE PIECES WERE RETRIEVED BY THE DOCTOR. ALL PIECES WERE VERIFIED AS HAVING BEEN RETRIEVED BY COMPARING THE TROCAR TO AN INTACT TROCAR. THE PATIENT'S ABDOMEN WAS IRRIGATED WITH A LITER OF SALINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CASE, "THE 5MM PORT TIP SHATTERED INTO MULTIPLE PIECES." THE PIECES WERE RETRIEVED BY THE DOCTOR. ALL PIECES WERE VERIFIED AS HAVING BEEN RETRIEVED BY COMPARING THE TROCAR TO AN INTACT TROCAR. THE PATIENT'S ABDOMEN WAS IRRIGATED WITH A LITER OF SALINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475296 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER SUSTAINABILITY SOLUTIONS LAKELAND CTS02 2969207

    Patients

    Seq Age Sex Outcome Treatment
    1