BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD003, 5MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 9148248 · Received October 2, 2019

    Report

    Report Number
    2027111-2019-00608
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 28, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K100959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CONFIRMED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS REPORT IS ALSO A FOLLOW-UP REPORT IN RESPONSE TO MEDWATCH #2400010000-2019-8032.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP CHOLE. DETAILED DESCRIPTION OF EVENT: "IN JULY WE HAD AN INZII BAG BREAK AND SHIPPED IT BACK FOR INSPECTION. ON 8/9, WE HAD A SECOND EVENT WITH A BAG BREAKING DURING A LAP CHOLE CASE. THERE IS A NOTE ON A REPORT THAT THE BAG WAS TO BE SENT TO THE VENDOR. WOULD YOU PLEASE LET ME KNOW IF YOU HAVE RECEIVED THE DEVICE FROM THE 8/9 EVENT, OR IF SOMEONE FROM OUR OR HAS CONTACTED YOU ABOUT THIS EVENT? I AM NOT SURE WHO IN OR HAD THIS DEVICE IN THEIR POSSESSION." THE PREVIOUS CASE IN JULY 2019 WAS LOGGED UNDER 2019-001810. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 13SEP2019 FROM APPL. MED. ACCT. MGR. MEDWATCH #2400010000-2019-8032 "DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, AS THE GALLBALADDER AND THE SPECIMEN BAG WERE BEING REMOVED FROM THE OPERATIVE SITE, THE SPECIMEN BAG BROKE. THE BAG WAS OUTSIDE FO THE PATIENT WHEN IT BROKE, AND THE AREA WAS CHECKED FOR REMAINING TIP OF THE BAG PORT. THE OPERATIVE SITE WAS IRRIGATED. TEAM MEMBERS ENSURED THAT ALL THE PIECES OF THE BAG WERE ACCOUNTED FOR AND NOT IN THE OPERATIVE WOUND SITE. THIS EVENT DID NOT RESULT IN PATIENT HARM OR DELAY IN THE PROCEDURE. NEITHER THE BAG OR THE ORIGINAL OUTSIDE PACKAGE WAS SAVED AND SO THE SPECIFIC LOT NUMER OF THE PRODUCT IS NOT KNOWN. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT RELATED TO THE EVENT. 44 YEAR OLD, WEIGHT: 81KG, ETHNICITY: NOT HISPANIC/LATINO, PRODUCT PROBLEM REPORTED. DEVICE NOT AVAILABLE FOR EVALUATION. SUSPECT MEDICAL DEVICE: CD003 UNKNOWN LOT NUMBER. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

    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: LAP CHOLE. DETAILED DESCRIPTION OF EVENT: "IN (B)(6) WE HAD AN INZII BAG BREAK AND SHIPPED IT BACK FOR INSPECTION. ON (B)(6), WE HAD A SECOND EVENT WITH A BAG BREAKING DURING A LAP CHOLE CASE. THERE IS A NOTE ON A REPORT THAT THE BAG WAS TO BE SENT TO THE VENDOR. WOULD YOU PLEASE LET ME KNOW IF YOU HAVE RECEIVED THE DEVICE FROM THE (B)(6) EVENT, OR IF SOMEONE FROM OUR OPERATING ROOM HAS CONTACTED YOU ABOUT THIS EVENT? I AM NOT SURE WHO IN OPERATING ROOM HAD THIS DEVICE IN THEIR POSSESSION." THE PREVIOUS CASE IN (B)(6) 2019 WAS LOGGED UNDER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2019 FROM APPL. MED. ACCT. MGR. MEDWATCH #(B)(4). "DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, AS THE GALLBLADDER AND THE SPECIMEN BAG WERE BEING REMOVED FROM THE OPERATIVE SITE, THE SPECIMEN BAG BROKE. THE BAG WAS OUTSIDE OF THE PATIENT WHEN IT BROKE, AND THE AREA WAS CHECKED FOR REMAINING TIP OF THE BAG PORT. THE OPERATIVE SITE WAS IRRIGATED. TEAM MEMBERS ENSURED THAT ALL THE PIECES OF THE BAG WERE ACCOUNTED FOR AND NOT IN THE OPERATIVE WOUND SITE. THIS EVENT DID NOT RESULT IN PATIENT HARM OR DELAY IN THE PROCEDURE. NEITHER THE BAG OR THE ORIGINAL OUTSIDE PACKAGE WAS SAVED AND SO THE SPECIFIC LOT NUMBER OF THE PRODUCT IS NOT KNOWN. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT RELATED TO THE EVENT. (B)(6) YEAR OLD, WEIGHT: (B)(6) KG, ETHNICITY: NOT HISPANIC/LATINO, PRODUCT PROBLEM REPORTED. DEVICE NOT AVAILABLE FOR EVALUATION. SUSPECT MEDICAL DEVICE: CD003 UNKNOWN LOT NUMBER. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941713 CD003, 5MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR