BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKVISTA OPTICAL PORT 5MMX100MM RIDGES

    MDR report key: 3912418 · Received May 13, 2014

    Report

    Report Number
    3003898360-2014-00311
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 18, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFR.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE CUSTOMER RETURNED ONE UNIT 405912R WECK VISTA OPTICAL PORT 5-10-12X100MM RIDGE FOR INVESTIGATION. THE SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. THE RETURNED DEVICE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED UNIT REVEALED THAT THE CANNULA APPEARS TO BE DAMAGED. IT APPEARS A PIECE OF THE TIP IS CHIPPED. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE REPORTED COMPLAINT OF A DAMAGED PORT DURING INSERTION OF AN INSTRUMENT WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED PORT WAS CONFIRMED TO HAVE A DAMAGED CANNULA. THE TIP OF THE CANNULA WAS CHIPPED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. OTHER REMARKS: THE IFU FOR THIS PRODUCT, L05489, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "BEFORE USING THE WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT, CONFIRM THE COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES." THE IFU ALSO INDICATES, "INSERTION AND REMOVAL OF INSTRUMENTS AND LAPAROSCOPE THROUGH THE CANNULA SHOULD BE DONE CAREFULLY TO PREVENT UNINTENTIONAL DAMAGE TO THE INTERNAL SEALS, WHICH MAY COMPROMISE INSUFFLATION. TO ENSURE SMOOTH INSERTION, AVOID INSERTING INSTRUMENTS AT AN ANGLE. ALWAYS ATTEMPT TO INSERT INSTRUMENTATION STRAIGHT DOWN THE CANNULA." THEREFORE, BASED UPON THE TIME OF DISCOVERY AND THE INFORMATION PROVIDED, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE CUSTOMER RETURNED ONE UNIT 405912R WECKVISTAOPTICALPORT 5-10-12X100MM RIDGE FOR INVESTIGATION. THE SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. THE RETURNED DEVICE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED UNIT REVEALED THAT THE DEVICE APPEARS TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED AND NO PIECES APPEAR TO BE MISSING (REFERENCE FILES (B)(4)). THE IFU FOR THIS PRODUCT, L05489, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "BEFORE USING THE WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT, CONFIRM THE COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES." THE IFU ALSO INDICATES, "INSERTION AND REMOVAL OF INSTRUMENTS AND LAPAROSCOPE THROUGH THE CANNULA SHOULD BE DONE CAREFULLY TO PREVENT UNINTENTIONAL DAMAGE TO THE INTERNAL SEALS, WHICH MAY COMPROMISE INSUFFLATION. TO ENSURE SMOOTH INSERTION, AVOID INSERTING INSTRUMENTS AT AN ANGLE. ALWAYS ATTEMPT TO INSERT INSTRUMENTATION STRAIGHT DOWN THE CANNULA." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THERE WAS NO VISUAL DEFECT OR ANOMALIES FOUND WITH THE RETURNED SAMPLE. OTHER REMARKS: THE REPORTED COMPLAINT OF THE END OF THE PORT BREAKING DURING USE COULD NOT BE CONFIRMED BASED UPON THE SAMPLE RECEIVED. VISUAL INSPECTION OF THE RETURNED SAMPLE DID NOT REVEAL ANY ANOMALIES OR DEFECTS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE IFU FOR THIS PRODUCT, L05489, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES , "BEFORE USING THE WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT, CONFIRM THE COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES." THE IFU ALSO INDICATES, "INSERTION AND REMOVAL OF INSTRUMENTS AND LAPAROSCOPE THROUGH THE CANNULA SHOULD BE DONE CAREFULLY TO PREVENT UNINTENTIONAL DAMAGE TO THE INTERNAL SEALS, WHICH MAY COMPROMISE INSUFFLATION. TO ENSURE SMOOTH INSERTION, AVOID INSERTING INSTRUMENTS AT AN ANGLE. ALWAYS ATTEMPT TO INSERT INSTRUMENTATION STRAIGHT DOWN THE CANNULA." THEREFORE, BASED ON THIS, NO VISUAL ISSUES WERE OBSERVED WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE END OF THE PORT BROKE INTO THE PT ABDOMEN RESULTING IN PIECES FALLING INTO HIS ABDOMEN. MOST PIECES RETRIEVED. THE PT CONDITION IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285617 WECKVISTA OPTICAL PORT 5MMX100MM RIDGES OPTICAL PORT GCJ TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1