BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY

    MDR report key: 18383943 · Received December 22, 2023

    Report

    Report Number
    3007208013-2023-00062
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    December 6, 2023
    Report Date
    February 5, 2024
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    KBD
    UDI-DI
    00887482121030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED THE PART NUMBER TO 67-5313. THE RETURNED DEVICE WAS CONFIRMED TO BE LOT NUMBER 030318 WHICH WAS PURCHASED IN AUGUST 2019. BASED ON THIS INFORMATION, THE DEVICE HAS BEEN IN USE FOR APPROXIMATELY 4.5 YEARS. A REVIEW OF THE RETURNED DEVICE NOTED SIGNIFICANT SIGNS OF WEAR AND TEAR ALONG THE CUTTING EDGE OF THE DEVICE CONFIRMING MANY USES. A HARDNESS TEST WAS PERFORMED ON THE DEVICE, WHICH CONFIRMED THAT THE PRODUCT WAS PROPERLY HARDENED DURING MANUFACTURING. BASED ON THE ABOVE INFORMATION, IT CAN BE DETERMINED THAT THE DEVICE DID NOT BREAK DUE TO A DEFICIENCY IN THE MATERIAL OR WORKMANSHIP OF THE PRODUCT. IT IS LIKELY THAT THE DEVICE EXPERIENCE EXTERNAL STRESS FOR IMPROPER CARE AND HANDLING THAT CAUSED A BREAK IN THE BLADE OF THE DEVICE. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS BEING RETURNED ON RMA 62796 FOR EVALUATION. THERE HAS BEEN A TOTALD OF 118 SOLD OF ALL LOTS WITH NO ADDITIONAL COMPLAINTS RECORDED. ONCE WE HAVE COMPLETED OUR EVALUATION OR IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE COMPLAINT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT DURING AN ENT PROCEDURE, THE TIP OF THE SCISSOR BROKE OFF. IT WAS NOTICED WHEN THE SCISSOR WAS REMOVED FROM THE SURGERY SITE THAT THE VERY TIP OF THE SCISSOR WAS MISSING. THE TIP WAS LOCATED INSIDE THE NOSE AND REMOVED WITH NO ADDITIONAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309072 SYMMETRY SCISSOR KBD SYMMETRY SURGICAL INC 030318 00887482121030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown