BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS3 IRIDIUM - LIGHT INTEGRATOR (BEAMCOMBINER)

    MDR report key: 20473928 · Received October 17, 2024

    Report

    Report Number
    9616637-2024-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    June 28, 2021
    Report Date
    October 17, 2024
    Manufacturer
    VISIONSENSE LTD.
    Product Code
    OWN
    UDI-DI
    10884521817555
    PMA / PMN Number
    K150018
    Removal / Correction Number
    Z-0283-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # (B)(4), WHICH IS ADDRESSING MDR REPORTING GU IDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS; THIS IS NOT A NEW MALFUNCTION/EVENT. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE UNIT HAD A CABLE/WIRE FAILURE. IT WAS REPORTED THAT THE LIGHT WAS NOT CLEAR OR WAS DIM. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR DUE TO MISHANDLING OR IMPROPER TRANSPORTATION. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, THE UNIT LASER HAD NO OUTPUT FROM BEAM COMBINER- FIBER PINCHED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287324 VS3 IRIDIUM - LIGHT INTEGRATOR (BEAMCOMBINER) CONFOCAL OPTICAL IMAGING OWN VISIONSENSE LTD. 161-0001 10884521817555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown