BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 9121171 · Received September 25, 2019

    Report

    Report Number
    2027111-2019-00601
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Report Date
    October 21, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 CONFIRMED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. DR PERFORMING A LAP CHOLE EXPERIENCED ISSUES WITH CD001. DR HAS USED THIS BAG FOR MANY YEARS. DR WAS USING CFF03 AND COR47 PORT, DR PLACED THE GALLBLADDER IN THE CD001 AND PULLED THE STRING TO TIGHTEN THE BAG READY FOR RETRIEVAL. DR SAID THE BAG DID NOT CLOSE CORRECTLY AND IT LEAKED BILE INTO THE ABDOMEN RESULTING HIM IN HAVING TO WASH THE ABDOMEN WITH 6 LITRES OF NS AND THE PATIENT HAS HAD TO STAY IN HOSPITAL WITH 2 DRAINS POST OP. DR SAID THAT THIS ISSUE HAD OCCURRED REPEATED ITSELF 3 TIMES NOW ON SEPARATE OCCASION. THE DEVICE WAS NOT KEPT DUE TO ITS CONDITION AFTER THE LEAK. ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA EMAIL ON 02SEP2019: I THINK I DID STATE THAT THE BAG LEAKED AT THE BEAD END AND DID NOT CLOSE PROPERLY AND DID NOT BURST IN MY ORIGINAL CER. ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA EMAIL ON 19SEP2019: HE CANNOT REMEMBER WHEN THE OTHER 2 TIMES OCCURRED UNFORTUNATELY. PATIENT STATUS: STAYED IN HOSPITAL FOR A NUMBER OF DAYS WITH 2 DRAINS IN ABD COMPLAINING. TYPE OF INTERVENTION: WASHED THE ABDOMEN WITH 6L OF NS AND PATIENT HAD TO STAY IN HOSPITAL WITH 2 DRAINS POST OP. CER 2019-002163 1 OF 3 CER 2019-002339 2 OF 3 CER 2019- 002340 3 OF 3.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. DR PERFORMING A LAP CHOLE EXPERIENCED ISSUES WITH CD001. DR HAS USED THIS BAG FOR MANY YEARS. DR WAS USING CFF03 AND COR47 PORT, DR PLACED THE GALLBLADDER IN THE CD001 AND PULLED THE STRING TO TIGHTEN THE BAG READY FOR RETRIEVAL. DR SAID THE BAG DID NOT CLOSE CORRECTLY AND IT LEAKED BILE INTO THE ABDOMEN RESULTING HIM IN HAVING TO WASH THE ABDOMEN WITH 6 LITRES OF NS AND THE PATIENT HAS HAD TO STAY IN HOSPITAL WITH 2 DRAINS POST OP. DR SAID THAT THIS ISSUE HAD OCCURRED REPEATED ITSELF 3 TIMES NOW ON SEPARATE OCCASION. THE DEVICE WAS NOT KEPT DUE TO ITS CONDITION AFTER THE LEAK. ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA EMAIL ON 02SEP2019: I THINK I DID STATE THAT THE BAG LEAKED AT THE BEAD END AND DID NOT CLOSE PROPERLY AND DID NOT BURST IN MY ORIGINAL CER. ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA EMAIL ON 19SEP2019: HE CANNOT REMEMBER WHEN THE OTHER 2 TIMES OCCURRED UNFORTUNATELY. PATIENT STATUS: STAYED IN HOSPITAL FOR A NUMBER OF DAYS WITH 2 DRAINS IN ABD COMPLAINING TYPE OF INTERVENTION: WASHED THE ABDOMEN WITH 6L OF NS AND PATIENT HAD TO STAY IN HOSPITAL WITH 2 DRAINS POST OP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908858 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization