BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED CANNULA W/OBTURATOR (TRANSLUCENT, PURPLE)

    MDR report key: 11613001 · Received April 5, 2021

    Report

    Report Number
    3014023545-2021-00002
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 13, 2021
    Manufacturer
    RENOVO, INC.
    Product Code
    NLM
    PMA / PMN Number
    K172097
    Removal / Correction Number
    10054580-01082020-R-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER SHIPPED OUTER CORRUGATED BOXES TO THE CONTRACT STERILIZER THAT INCLUDE INNER BOXES THAT ARE ADDRESSED TO THE END CUSTOMER. THE COMPANY SHIPPED THE STERILIZER 6 OF THESE OUTER BOXES, BUT THE STERILIZER ONLY RECEIVED 5 OUT OF THE 6 BOXES. THE COMPANY WAITED SEVERAL DAYS TO SEE IF THE 6TH BOX WOULD ARRIVE AT THE STERILIZER, BUT IT NEVER DID. AT THAT POINT, THE COMPANY INITIATED A CLAIM WITH (B)(6). IN LOOKING AT THE (B)(6) RECORDS, THE OUTER PACKAGE WAS RECEIVED AT A (B)(6) FACILITY ON (B)(6). ON THE (B)(6), THE INNER BOXES WERE PICKED UP FROM THAT (B)(6) LOCATION AND SHIPPED TO THE CUSTOMERS. IT IS UNKNOWN WHY THE OUTER BOX (ADDRESSED TO THE STERILIZER) WAS OPENED BY (B)(6) TO EXPOSE THE 3 INNER BOXES. AS SOON AS THE COMPANY WAS AWARE THAT NON-STERILE COMPONENTS HAD BEEN DELIVERED TO THE END USERS THEY REACHED OUT TO INSTRUCT THE FACILITIES TO IMMEDIATELY QUARANTINE THE DEVICES AND SHIP THEM BACK TO THE MANUFACTURER AS SOON AS POSSIBLE. TWO OF THE THREE SITES WHO HAD RECEIVED THE NON-STERILE PRODUCT HAD USED AT LEAST ONE OF THE DEVICES. THE FACILITY WAS ABLE TO NARROW IT DOWN TO SEVERAL PATIENTS WHO COULD HAVE BEEN EXPOSED BUT NOT THE EXACT SINGLE PATIENT.

    Description of Event or Problem · 1

    A NON-STERILE TROCAR WAS USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514329 THREADED CANNULA W/OBTURATOR (TRANSLUCENT, PURPLE) LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM RENOVO, INC. TC-214116 L-008926-16037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR