BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF03, 5X100 KII FIOS Z-THR 6/BX

    MDR report key: 15506158 · Received September 29, 2022

    Report

    Report Number
    2027111-2022-00747
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 17, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123550
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A BROKEN OBTURATOR SHAFT. THE WALL THICKNESS OF THE SHAFT WAS MEASURED AND MET SPECIFICATIONS. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS DUE TO USE ERROR. THE OBTURATOR IS NOT DESIGNED FOR INSERTION WITHOUT THE CANNULA, AS THE CANNULA PROVIDES ADDITIONAL STRUCTURAL INTEGRITY. IT IS LIKELY THAT THE OBTURATOR SHAFT WAS UNABLE TO WITHSTAND THE FORCE EXERTED ON IT DURING INSERTION WITHOUT THE CANNULA, CAUSING IT TO FRACTURE.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: REMOVAL OF GASTRIC BAND. EVENT DESCRIPTION: [SURGEON] WAS INSERTING THE PORT INTO THE PATIENT IN ORDER TO PUT IN A LIVER RETRACTOR. [SENIOR ODP] WAS SITTING NEXT TO THE PATIENT AND NOTICED THE OBTURATOR START TO BEND WHEN [SURGEON] WAS INSERTING IT. THE ODP NOTIFIED [SURGEON] AND WHEN [SURGEON] REMOVED THE OBTURATOR FROM THE SLEEVE HE DIDN'T SEEM TO THINK IT HAD SNAPPED. WHEN HE PASSED THE OBTURATOR TO THE ODP ON INSPECTION THE TROCAR HAD BROKEN ON ONE SIDE AND WAS STILL ATTACHED THE OTHER SIDE, SO A PARTIAL BREAK. THE ODP SAID AS SOON AS THERE WAS PRESSURE AT THE TIP OF THE OBTURATOR YOU COULD NOTICE THE DEFECT HIGHER UP IN THE SLEEVE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 14SEP2022: THE SURGEON WANTED TO MAKE AN OPENING TO INSERT A LIVER RETRACTOR IN ORDER TO DO THIS HE ONLY USES THE OBTURATOR WITHOUT THE SLEEVE SO HE ONLY HAS A SMALL FASCIAL DEFECT. THE 5MM OBTURATOR WAS INSERTED AND THE OBTURATOR BENT, WHEN IT WAS REMOVED IT WAS NOTICED THAT THE TROCAR HAD SNAPPED ON ONE SIDE. NO SLEEVES WERE USED IN CONJUNCTION WITH THE OBTURATOR SO THE INITIAL REPORT WAS INCORRECT. PATIENT STATUS: PATIENT HAD NORMAL RECOVERY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: REMOVAL OF GASTRIC BAND. EVENT DESCRIPTION: [SURGEON NAME REDACTED] WAS INSERTING THE PORT INTO THE PATIENT IN ORDER TO PUT IN A LIVER RETRACTOR. [SENIOR ODP NAME REDACTED] WAS SITTING NEXT TO THE PATIENT AND NOTICED THE OBTURATOR START TO BEND WHEN [SURGEON NAME REDACTED] WAS INSERTING IT. THE ODP NOTIFIED [SURGEON NAME REDACTED] AND WHEN [SURGEON NAME REDACTED] REMOVED THE OBTURATOR FROM THE SLEEVE HE DIDN'T SEEM TO THINK IT HAD SNAPPED. WHEN HE PASSED THE OBTURATOR TO THE ODP ON INSPECTION THE TROCAR HAD BROKEN ON ONE SIDE AND WAS STILL ATTACHED THE OTHER SIDE, SO A PARTIAL BREAK. THE ODP SAID AS SOON AS THERE WAS PRESSURE AT THE TIP OF THE OBTURATOR YOU COULD NOTICE THE DEFECT HIGHER UP IN THE SLEEVE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP. ON 14SEP2022: THE SURGEON WANTED TO MAKE AN OPENING TO INSERT A LIVER RETRACTOR IN ORDER TO DO THIS HE ONLY USES THE OBTURATOR WITHOUT THE SLEEVE SO HE ONLY HAS A SMALL FASCIAL DEFECT. THE 5MM OBTURATOR WAS INSERTED AND THE OBTURATOR BENT, WHEN IT WAS REMOVED IT WAS NOTICED THAT THE TROCAR HAD SNAPPED ON ONE SIDE. NO SLEEVES WERE USED IN CONJUNCTION WITH THE OBTURATOR SO THE INITIAL REPORT WAS INCORRECT. PATIENT STATUS: PATIENT HAD NORMAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588019 CTF03, 5X100 KII FIOS Z-THR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTF03 1439958 00607915123550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RETRACTOR