BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 19646137 · Received July 1, 2024

    Report

    Report Number
    3012883202-2024-00024
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 12, 2023
    Report Date
    July 1, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ANALYZING THE REPORT AND UNIT RECEIVED, THE ALLEGED EVENT WAS CONFIRMED. THE DEVICE SENT BACK TO US FOR INVESTIGATION WAS FURTHER ANALYZED TO DETERMINE THE CAUSE: REVIEW OF THE EVIDENCE PROVIDED IDENTIFIED DAMAGE TO THE LOCATOR COMPONENT OF THE DEVICE. EACH PATIENT SHOULD BE GIVEN THE ESTABLISHMENT LABS ¿MOTIVA FLORA® TISSUE EXPANDER: INFORMATION FOR THE PATIENT¿ DOCUMENT DURING HER SURGICAL CONSULTATION. IT IS THE SURGEON¿S RESPONSIBILITY TO ENSURE THAT THIS HAPPENS, AND IT IS A REQUIREMENT FOR THE USE OF THE DEVICE. THE PATIENT MUST BE GIVEN ENOUGH TIME TO READ AND COMPLETELY UNDERSTAND THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH TISSUE EXPANDER-BASED BREAST RECONSTRUCTION SURGERY. IN ORDER TO DOCUMENT A SUCCESSFUL INFORMED CONSENT PROCESS, THE PATIENT, A WITNESS, AND THE SURGEON SHOULD SIGN THE ¿INFORMED CONSENT DOCUMENT,¿ WHICH WILL BE PART OF THE PATIENT¿S MEDICAL FILE. THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: THE MOTIVA FLORA® TISSUE EXPANDER MUST BE FILLED VIA AN INTEGRATED PORT, WHICH IS FOUND VIA AN EXTERNAL MOTIVA FLORA® PORT LOCATOR THROUGH THE RFID SIGNAL EMITTED BY THE AIR WOUND COIL PLACED INSIDE THE NEEDLE STOP. THE AIR WOUND COIL IS INTENDED TO INTERACT WITH THE PORT LOCATOR TO IDENTIFY THE LOCATION OF THE INJECTION PORT MOTIVA FLORA® TISSUE EXPANDER CONTAINS A RFID TRANSPONDER THAT PROVIDES AN ELECTRONIC SERIAL NUMBER (ESN) THAT IS UNIQUE TO EACH DEVICE, SO IT CAN BE MATCHED TO A DATABASE OF INTERNAL RECORDS FOR TRACEABILITY. THE USE OF AN RFID SIGNAL TO IDENTIFY THE CENTER OF THE INJECTION PORT IS AN INNOVATIVE TECHNOLOGY NOT AVAILABLE IN OTHER TISSUE EXPANDERS ON THE MARKET. MALFUNCTION OF THE EXPANDER IN THE EARLY POSTOPERATIVE PERIOD IS RARE. PROPER PLACEMENT OF THE EXPANDER AND CONFIRMATION OF PORT PATENCY AFTER SKIN CLOSURE DURING THE OPERATIVE PROCEDURE SHOULD BE SUFFICIENT TO AVOID NEED FOR ANY REVISION SURGERY. A MOTIVA FLORA® PORT LOCATOR IS REQUIRED TO LOCATE THE INJECTION SITE. IT IS AN EXTERNAL REUSABLE DEVICE THAT USES RFID TECHNOLOGY WHICH IS COMPATIBLE ONLY WITH THE MOTIVA FLORA® TISSUE EXPANDER. WHILE THE INJECTION SITE CAN BE GENERALLY IDENTIFIED BY PALPATION, TO AVOID BREAST TISSUE EXPANDER PERFORATION ALWAYS VERIFY AND CONFIRM ITS LOCATION USING THE MOTIVA FLORA® PORT LOCATOR BEFORE EACH FILLING. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE FILLING PROCEDURE THERE WAS NO SIGNAL DETECTABLE FROM THE INJECTION PORT. TWO DIFFERENT PORT LOCATORS WERE USED BUT THE PROBLEM PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564276 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 21030795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown