BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFF71, 12X150 KII FIOS ADVFIX 6/BX

    MDR report key: 8224052 · Received January 7, 2019

    Report

    Report Number
    2027111-2019-00310
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 19, 2018
    Report Date
    March 1, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123048
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY AN INSTRUMENT OR OBJECT THAT CAME IN CONTACT WITH THE CANNULA TIP DURING THE PROCEDURE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE PROCESS ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR. THIS REPORT IS TO FOLLOW-UP MEDWATCH # MW5082560.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: ROBOTIC HYSTERECTOM.Y EVENT DESCRIPTION: WHILE PERFORMING A ROBOTIC HYSTERECTOMY, PROCEEDED TO DO A CUT DOWN RATHER THAN USING AN INSUFFLATION NEEDLE. INSERTED A 12MM LONG FIXATION TROCAR IN THE PATIENT, AND THEN INSUFFLATED. WHILE PLACING THE OTHER PORTS, DR. NOTICED THAT A PORTION OF THE 12MM LONG SLEEVE WAS MISSING A PIECE OF THE PLASTIC, JUST PAST THE BALLOON CUFF. AFTER THOROUGH SEARCHING, THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED. THE ENTIRE TROCAR WAS THEN REPLACED, AND WE CONTINUED WITH THE PROCEDURE. METHOD OF INSERTION WAS NORMAL TWISTING MOTION, NOT AT ALL FORCEFUL. MEDWATCH #5082560 RECEIVED VIA MAIL ON 4FEB2019 ROBOTIC HYSTERECTOMY IN PROCESS. MD'S PROCEEDED TO DO A CUT DOWN RATHER THAN USING A VERRES NEEDLE ON THE PATIENT AND INSERTED A 12MM LONG FIXATION TROCAR IN THE PATIENT, AND THEN INSUFFLATED. WHILE PLACING THE OTHER PORTS, MD NOTICED THAT A PORTION OF THE 12MM LONG SLEEVE WAS MISSING A PIECE OF THE PLASTIC, JUST PAST THE BALLOON CUFF. AFTER THROUGH SEARCHING, THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT'S ABDOMEN AND SAFELY REMOVED THROUGH A PORT SITE. THE ENTIRE TROCAR WAS THEN REPLACED, AND THE PROCEDURE CONTINUED. THE ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF ADHESIONS WAS COMPLETED WITHOUT FURTHER INCIDENT BY MD'S. THE LOT NUMBER FOR THE APPLIED MEDICAL CFF71 TROCAR WAS 1332862. BOTH THE ADVANCED FIXATION SLEEVE AND THE PIECE THAT WAS BROKEN OFF WERE PLACED IN A BIOHAZARD BAG AND SEQUESTERED IN THE DIRECTOR OF SURGERY'S OFFICE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM RN ON THURSDAY, 7FEB2019 ACCORDING TO OUR RECORDS THE LOT NUMBER WAS 1325530, MODEL CFF71. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 08FEB2019 FROM APPLIED MEDICAL ACCOUNT MGR. "I CONTACTED THE ACCOUNT AND PER [] SHE SAID THAT THE DAMAGED PRODUCT MUST HAVE ACCIDENTALLY GOTTEN THROWN AWAY." INTERVENTION: THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED. PATIENT STATUS: FINE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: WHILE PERFORMING A ROBOTIC HYSTERECTOMY, PROCEEDED TO DO A CUT DOWN RATHER THAN USING AN INSUFFLATION NEEDLE. INSERTED A 12MM LONG FIXATION TROCAR IN THE PATIENT, AND THEN INSUFFLATED. WHILE PLACING THE OTHER PORTS, DR. NOTICED THAT A PORTION OF THE 12MM LONG SLEEVE WAS MISSING A PIECE OF THE PLASTIC, JUST PAST THE BALLOON CUFF. AFTER THOROUGH SEARCHING, THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED. THE ENTIRE TROCAR WAS THEN REPLACED, AND WE CONTINUED WITH THE PROCEDURE. METHOD OF INSERTION WAS NORMAL TWISTING MOTION, NOT AT ALL FORCEFUL. INTERVENTION: THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED PATIENT STATUS: FINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16414 CFF71, 12X150 KII FIOS ADVFIX 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES CFF71 1325530 00607915123048

    Patients

    Seq Age Sex Outcome Treatment
    1