BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 12652211 · Received October 18, 2021

    Report

    Report Number
    2027111-2021-00678
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    January 19, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, SIX REPRESENTATIVE STERILE UNITS WERE RETURNED. IN ADDITION, PHOTOGRAPHS OF THE EVENT UNIT WERE PROVIDED, CONFIRMING THE COMPLAINANT¿S EXPERIENCE OF THE SHAFT¿S SCRAPINGS. NO NON-CONFORMANCES WERE OBSERVED ON THE SIX STERILE UNITS RETURNED, AND THE UNITS FUNCTIONED AS INTENDED. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY THE SHAFT COMING IN CONTACT WITH THE TIP OF THE METAL CANNULA, WHICH IS POTENTIALLY SHARP. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS EVENT WAS INITIALLY REPORTED BASED ON THE INITIAL DESCRIPTION OF THE EVENT. HOWEVER, PER ADDITIONAL INFORMATION RECEIVED, APPLIED MEDICAL DETERMINED THAT THIS EVENT IS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION BUT LOT NUMBER IS PROVIDED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAP. CHOLECYSTECTOMIE. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 5: 2021-002214, COMPLAINT 2 OF 5: 2021-002216, COMPLAINT 3 OF 5: 2021-002287, COMPLAINT 4 OF 5: 2021-002288, COMPLAINT 5 OF 5: 2021-002289. ACCORDING TO HER THERE MUST HAVE BEEN SOME CHANGES LATELY. BESIDES THE CHANGED COLOUR ALSO THE SIZE SEEMS TO BE DIFFERENT AS THEY ARE FACING CHALLENGES WHEN TRYING TO REMOVE THEM. IT HAPPENED SEVERAL TIMES THAT PLASTIC PEELED OFF CIRCULARLY AND ENDED UP IN THE PATIENT. [NAME] COULD CONFIRM THAT THIS OCCURRED WITH THE LAST 2 LOT NUMBERS THEY RECEIVED FROM US: 1410863 AND 1419985. THE CD001 WITH LOT NUMBER 1410863 ARE NOT AVAILABLE FOR RETURN ANYMORE AS THEY HAVE BEEN DISPOSED OF. LOT NUMBER 1419985 IS AVAILABLE: 1 EA UNSTERILE AND 9 STERILE EA. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 21SEP2021: IT HAPPENED SEVERAL TIMES THAT PLASTIC PEELED OFF CIRCULARLY AND ENDED UP IN THE PATIENT. [BRAND NAME] TROCAR (MULTIUSE) BEING USED, SINCE A LONG TIME, NEVER HAD ISSUES BEFORE. ISSUES ONLY OCCUR WITH THOSE TROCARS, AND ONLY SINCE THE LAST TWO BOXES. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28-SEP-2021: IT HAPPENED 4 OR 5 TIMES, AND THE PLASTIC PEELED OFF FROM THE BAG. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL CUSTOMER RELATIONS - EU VIA EMAIL ON 7-OCT-2021: MRS. [NAME] FROM THE OR INFORMED ME THAT THE EVENT UNIT HAS BEEN DISPOSED OF AND ONLY 6 STERILE EA ARE AVAILABLE FOR RETURN. CLARIFICATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL EU ON 13-OCT-2021: THE CUSTOMER ALWAYS USES REUSABLE TROCARS IN CONJUNCTION WITH THE INZII BAG, AND NEVER HAD THIS ISSUE BEFORE. THE PLASTIC PEELING OFF OF THE INZII BAG ONLY OCCURS WHEN THEY¿RE USING REUSABLE TROCARS, AND ONLY WITH THE LAST TWO BOXES OF INZII BAGS THEY RECEIVED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02-NOV-2021: THE SCRAPINGS DON'T COME FROM THE BAG, BUT FROM THE SHAFT. THE SURGEON AND THE REPRESENTATIVE MEASURED THE SHAFT WITH A CALLIPER ON THE DISTAL AND PROXIMAL END, AND FOUND IRREGULARITIES. THE REUSABLE TROCAR HAS A 10MM DIAMETER. THE MANUFACTURER OF THE TROCAR INVESTIGATED 2 OF THE TROCARS WITH WHICH THE ISSUE HAS OCCURRED. BOTH 10MM TROCARS HAVE A CONSISTENT 9MM INNER DIAMETER. THE RETRIEVAL BAG FITS INTO THE 10MM TROCAR, BUT WHEN YOU PULL ON THE SHAFT, SOME PLASTIC IS SCRAPED OFF, WHICH YOU WON'T NOTICE IF YOU DON'T LOOK CLOSELY. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAP. CHOLECYSTECTOMIE. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 5: (B)(4). COMPLAINT 2 OF 5: (B)(4). COMPLAINT 3 OF 5: (B)(4). COMPLAINT 4 OF 5: (B)(4). COMPLAINT 5 OF 5: (B)(4). ACCORDING TO HER THERE MUST HAVE BEEN SOME CHANGES LATELY. BESIDES THE CHANGED COLOUR ALSO THE SIZE SEEMS TO BE DIFFERENT AS THEY ARE FACING CHALLENGES WHEN TRYING TO REMOVE THEM. IT HAPPENED SEVERAL TIMES THAT PLASTIC PEELED OFF CIRCULARLY AND ENDED UP IN THE PATIENT. [NAME] COULD CONFIRM THAT THIS OCCURRED WITH THE LAST 2 LOT NUMBERS THEY RECEIVED FROM US: 1410863 AND 1419985. THE CD001 WITH LOT NUMBER 1410863 ARE NOT AVAILABLE FOR RETURN ANYMORE AS THEY HAVE BEEN DISPOSED OF. LOT NUMBER 1419985 IS AVAILABLE: 1 EA UNSTERILE AND 9 STERILE EA. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 21SEP2021: IT HAPPENED SEVERAL TIMES THAT PLASTIC PEELED OFF CIRCULARLY AND ENDED UP IN THE PATIENT. [BRAND NAME] TROCAR (MULTIUSE) BEING USED, SINCE A LONG TIME, NEVER HAD ISSUES BEFORE. ISSUES ONLY OCCUR WITH THOSE TROCARS, AND ONLY SINCE THE LAST TWO BOXES. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28-SEP-2021: IT HAPPENED 4 OR 5 TIMES, AND THE PLASTIC PEELED OFF FROM THE BAG. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL CUSTOMER RELATIONS - EU VIA EMAIL ON 7-OCT-2021: MRS. [NAME] FROM THE OR INFORMED ME THAT THE EVENT UNIT HAS BEEN DISPOSED OF AND ONLY 6 STERILE EA ARE AVAILABLE FOR RETURN. CLARIFICATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL EU ON 13-OCT-2021: THE CUSTOMER ALWAYS USES REUSABLE TROCARS IN CONJUNCTION WITH THE INZII BAG, AND NEVER HAD THIS ISSUE BEFORE. THE PLASTIC PEELING OFF OF THE INZII BAG ONLY OCCURS WHEN THEY¿RE USING REUSABLE TROCARS, AND ONLY WITH THE LAST TWO BOXES OF INZII BAGS THEY RECEIVED. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: RETRIEVAL OF SEPARATED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548961 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 1410863 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown WOLF REUSABLE TROCARS