BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 9842338 · Received March 17, 2020

    Report

    Report Number
    3006560326-2020-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OUP
    PMA / PMN Number
    K192185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, A CELLFINA DISPOSABLE KIT WAS RECEIVED BY MERZ/ULTHERA UNDER THE RETURNING MATERIALS AUTHORIZATION NUMBER ASSOCIATED WITH THIS CASE. THE DEVICE DID NOT HAVE A VISIBLE LOT NUMBER; HOWEVER, IT WAS EVALUATED AS A DEVICE THAT WAS POTENTIALLY ASSOCIATED WITH THE REPORTED ISSUES OF LOSS OF VACUUM PRESSURE AND COMPONENT DAMAGE. A VISUAL INSPECTION OF THE RETURNED VACUUM HAND PIECE REVEALED WEAR AND TEAR AROUND THE ELASTOMERIC SEPTUM. FURTHER EVALUATION REVEALED THE BLADE WAS INSERTED INTO THE ELASTOMERIC SEPTUM, WHICH CREATED A PUNCTURE. THE PUNCTURE IN THE ELASTOMERIC SEPTUM CAUSED A LARGE TEAR WHICH WOULD LIKELY RESULT IN A LOSS OF VACUUM PRESSURE. THE GUIDANCE PLATFORM WAS ALSO INSPECTED, AND DID NOT SHOW ANY SIGNS OF ABUSE, WEAR, TEAR, OR TAMPERING. BASED ON THESE FINDINGS, THE REPORTED ISSUE OF CK1 COMPONENT DAMAGE WAS CONFIRMED DURING EVALUATION OF THE RETURNED DEVICE. THE REPORTED ISSUE OF VACUUM LOSS OF PRESSURE WAS NOT CONFIRMED VIA MECHANICAL TESTING; HOWEVER, THE PRESENCE OF THE TEAR WOULD LIKELY CONTRIBUTE TO THE ISSUE. AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE LOT COMPLAINT HISTORY AND LOT HISTORY RECORD WAS NOT POSSIBLE. A REVIEW OF THE CURRENT CELLFINA PRODUCT COMPLAINT TRENDING ANALYSIS FOR THE CONDITIONS OF "VACUUM LOSE OF PRESSURE" AND "CK1 COMPONENT DAMAGE" REVEALED THESE ISSUES HAVE NOT BEEN REPORTED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REPORTED TO BE SHIPPED FROM THE CUSTOMER TO A THIRD PARTY DECONTAMINATION LABORATORY; HOWEVER, IT HAS NOT BEEN RECEIVED AS OF THIS REPORT. THE PHYSICIAN ALLEGED THAT THE LOT NUMBER OF THE CELLFINA DISPOSABLE KIT WAS NOT RECORDED; AS SUCH, A LOT HISTORY RECORD REVIEW AND LOT COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. A REVIEW OF THE CELLFINA SYSTEM PRODUCT COMPLAINT TRENDING ANALYSIS OF "VACUUM LOSS OF PRESSURE" AS OF MAY 2020 REVEALED THAT THIS REPORTED ISSUE HAS NOT OCCURRED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PHYSICIAN CONFIRMED THAT THE LOSS OF VACUUM PRESSURE OCCURRED DURING TISSUE CUTTING; HOWEVER, NO PATIENT IMPACT OCCURRED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR INVESTIGATION; HOWEVER, IT HAS NOT BEEN RECEIVED AS OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO A (B)(6) ACCOUNT MANAGER ON (B)(6) 2020 INFORMATION REGARDING A CELLFINA SYSTEM DEVICE MALFUNCTION. THE REPORTER ALLEGED THAT THE VACUUM PRESSURE OF A CELLFINA DISPOSABLE KIT DIMINISHED AS TREATMENT WAS PERFORMED. NORMAL PRESSURE WAS ACHIEVED INITIALLY; HOWEVER, THE MEMBRANE SEAL ALLEGEDLY DID NOT FUNCTION PROPERLY AFTER APPROXIMATELY 70 PERCENT OF THE TREATMENT HAD BEEN PERFORMED. THE MEMBRANE THROUGH WHICH THE NEEDLE WAS PUSHED BECAME WIDER AND LET AIR LEAK THROUGH, RESULTING IN INSUFFICIENT PRESSURE OF THE VACUUM. THE REPORTER ALLEGED THAT NO PATIENT INJURY OCCURED IN CONJUNCTION WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306113 THE CELLFINA SYSTEM THE CELLFINA SYSTEM OUP MERZ NORTH AMERICA, INC. CK1 - EU

    Patients

    Seq Age Sex Outcome Treatment
    1