BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3895409 · Received June 25, 2014

    Report

    Report Number
    0001056128-2014-00076
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLM
    PMA / PMN Number
    K132629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED EVIDENCE OF CLINICAL USE INCLUDING THE PRESENCE OF BIOLOGICAL MATERIAL. THE CANNULA SLEEVED WAS OBSERVED TO BE BROKEN IN TWO PIECES SUBSTANTIATING THE REPORTED ISSUE. RESULTS OF THE INVESTIGATION CONFIRMED THE REPORTED ISSUE AS THE CANNULA SLEEVE WAS BROKEN. AS THE DAMAGE OCCURRED INTRA-OPERATIVELY 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. THE INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE REPROCESSED ETHICON ENDOPATH® XCEL UNIVERSAL TROCAR STABILITY SLEEVE (IFU) STATES: "USE CAUTION WHEN INTRODUCING OR REMOVING INSTRUMENTS THROUGH THE TROCAR SLEEVE IN ORDER TO PREVENT INADVERTENT DAMAGE TO THE SEALS WHICH COULD RESULT IN LOSS OF PNEUMOPERITONEUM. SPECIAL CARE SHOULD BE USED WHEN INSERTING SHARP OR ANGLED EDGED ENDOSCOPIC INSTRUMENTS TO PREVENT TEARING THE SEAL." "DO NOT USE EXCESSIVE FORCE." 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. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 0002090040-2013-00002 FILED ON (B)(4) 2013 WHERE AN INCISION HAD TO BE MADE LARGER TO RETRIEVE A BROKEN PIECE OF A TIP OF A TROCAR. 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, "THE TROCAR SHAFT ON THE SLEEVE SNAPPED IN HALF." THE BROKEN PART FELL INTO THE PATIENT, BUT WAS EASILY RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY MEDICAL TREATMENT OR INTERVENTION. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370130 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 2CB5LTRR 2805696

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR