BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENS 4K A/C CAMERA HEAD

    MDR report key: 11509927 · Received March 17, 2021

    Report

    Report Number
    1643264-2021-01065
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    UDI-DI
    00885556720790
    PMA / PMN Number
    K191177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT IDENTIFY ANY ISSUES. FUNCTIONAL EVALUATION DID NOT REVEAL ANY PROBLEMS. THE COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE LOT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE IN THE LENS 4K A/C CAMERA HEAD WAS INTERMITTENT. NO CASE REPORTED, THEREFORE THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405861 LENS 4K A/C CAMERA HEAD LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC. 72205058 00885556720790

    Patients

    Seq Age Sex Outcome Treatment
    1