BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA PROVU HANDPIECE

    MDR report key: 13095201 · Received December 28, 2021

    Report

    Report Number
    3006443171-2021-00018
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN : ¨PATIENT FOLLOWED UP. HAD AN MRI. NO LESIONS SEEN BUT THERE IS STILL A VISIBLE AND PALPABLE SOFT TISSUE MASSAGE. PATIENT IS ON PAIN MEDS AND DOING GOOD SO FAR.¨ NO OTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON NOVEMBER 15TH AND DURING A POST OP VISIT A LUMP AND BRUISING WAS OBSERVED ON THE VISIT ON THE LEFT SIDE OF THE PELVIS. THE PATIENT WAS NOT READMITTED TO THE HOSPITAL AND WAS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991370 ACESSA PROVU HANDPIECE COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG ACESSA HEALTH INC. 7300

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ACESSA PROVU CONSOLE.