BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASER ASPIRATING CANNULA

    MDR report key: 14718539 · Received June 16, 2022

    Report

    Report Number
    3011423170-2022-00078
    Event Type
    Injury
    Date Received
    June 16, 2022
    Report Date
    May 5, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K110306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RETURNED AND WILL BE EVALUATED SHORTLY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CANNULA WAS RETURNED FOR EVALUATION. SERVICE WAS ABLE TO CONFIRM THAT THE CANNULA WAS BROKEN AT THE BASE. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. COMPLAINT TYPE IDENTIFIED WITHIN RISK ANALYSIS AND PERFORMING WITHIN ANTICIPATED RATE. NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: REVISED H6 INVESTIGATION CONCLUSIONS CODE FROM 4307 TO 4315 CORRECTION TO H11 NARRATIVE: CONFIRMED DAMAGED CANNULA. CANNULA APPEARED TO BE SEPARATED FROM THE HUB. THERE WERE NO OBVIOUS SIGN OF BOND DEGRADATION FROM A CHEMICAL SOLUTION BETWEEN THE LUMAN AND HUB THAT MIGHT HAVE BEEN USED DURING CLEANING PROCESS. EVALUATION FOUND THE DIMENSIONS OF THE CANNULA WERE WITHIN THE PRODUCT DESIGN. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE FOUND.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT DURING TREATMENT WITH A VASERLIPO SYSTEM THEY HAD A CANNULA BREAK LEADING TO A DELAY IN SURGERY OF 20 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CANNULA DID NOT BREAK WHILE INSIDE OF THE PATIENT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795719 VASER ASPIRATING CANNULA SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC 810GHBU3726VXNR 222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention