BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW IMP NEEDLE DRIVER STRAIGHT

    MDR report key: 11132003 · Received January 7, 2021

    Report

    Report Number
    1320894-2021-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 16, 2020
    Report Date
    March 12, 2021
    Manufacturer
    A B MEDICA SAS
    Product Code
    GCJ
    PMA / PMN Number
    K140101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF "PIECE BROKE OFF AND FELL INTO PATIENT; RETRIEVED" IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED AS CONMED IS NOT THE MANUFACTURER. A 2 YEAR LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS A VALID LOT NUMBER WAS NOT PROVIDED. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN OR FRACTURED COMPONENTS PRIOR TO EACH USE. TO AVOID DAMAGE TO THE WORKING END, CAREFULLY INSERT THE DEVICE THROUGH THE WORKING CHANNEL, E.G. TROCAR. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    PROCODE-GEI. THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C-LIL-NS-31 DEVICE WAS BEING USED DURING A HYSTERECTOMY ON (B)(6) 2020 WHEN "A PIECE BROKE OFF AND FELL INTO PATIENT." UPON FURTHER ASSESSMENT, IT WAS DISCOVERED THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A FEW MINUTES DELAY. THERE WAS NO REPORT OF INJURY/IMPACT FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32771 LOW IMP NEEDLE DRIVER STRAIGHT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ A B MEDICA SAS

    Patients

    Seq Age Sex Outcome Treatment
    1