BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTS02, 5X100 KII SLEEVE ZTHR 12/BX

    MDR report key: 5265439 · Received December 3, 2015

    Report

    Report Number
    2027111-2015-00866
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION ALONG WITH FIVE (5) STERILE UNITS FROM THE SAME LOT. UPON INSPECTION OF THE EVENT UNIT, ENGINEERING CONFIRMED THE CANNULA SLEEVE HAD FRACTURED AT THE TIP AND IN THE Z-THREAD REGION. ENGINEERING TRIED TO SIMULATE THE EVENT ON ONE (1) RETURNED STERILE UNIT AND FOUND THAT IT FRACTURED IN A SIMILAR MANNER AS THE EVENT UNIT. THE ADDITIONAL FOUR (4) STERILE UNITS WERE FOUND TO FUNCTION PROPERLY AND MET DESIGN SPECIFICATIONS. THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, APPLIED MEDICAL HAS OPENED A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) REPORT TO FURTHER ELEVATE AND TRACK THIS INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS TO MITIGATE THIS TYPE OF INCIDENT. IN ACCORDANCE WITH 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC INGUINAL HERNIA - CTF03 LOT# 1250998 & CTS02 LOT#1250648. "SURGEON STATED AT THE END OF THE CASE HE AIMED THE SCOPE AT THE TROCAR TO WATCH IT COME OUT AND NOTICED LARGE PIECES OF THE TROCARS SLEEVE MISSING. THIS IS THE SLEEVE THAT IS BEING SENT BACK AND IT IS COMPLETELY SHATTERED. HE THEN PUT IN ANOTHER TROCAR TO FIND THE PIECES AND UPON DOING SO, THE TIP OF HIS NEW TROCAR BROKE OFF. THEY DID NOT SAVE THIS TROCAR, BUT FOUND THE PIECE THAT BROKE OFF. THE SURGEON SEARCHED FOR A WHILE LAPAROSCOPICALLY FINDING ONE PIECE, BUT HAD TO CONVERT TO OPEN TO FIND THE OTHER PIECES- TOTALING 45-50 EXTRA MINUTES LOOKING FOR THE TROCAR PIECES. THE SURGEON WAS USING ONLY SCISSORS AND A BULLET IN THE TROCAR THAT SHATTERED. IT WAS PLACED LATERALLY ON THE PATIENTS RIGHT. " *TYPE OF INTERVENTION- "HAD TO CONVERT TO OPEN 8CM TO FIND FRAGMENTS. ONE SMALL PIECE OF TROCAR LEFT INSIDE PATIENT." PATIENT STATUS - "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796417 CTS02, 5X100 KII SLEEVE ZTHR 12/BX GCJ GCJ APPLIED MEDICAL CTS02 1250648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention