BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 16907530 · Received May 10, 2023

    Report

    Report Number
    3003249645-2023-00017
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 30, 2023
    Report Date
    September 1, 2023
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOOK 3PK N5 FOR HOOK HANDLE (CEV2295A) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: EVALUATION OF THE 3PK HOOK FOR HOOK HANDLE VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE END OF THE MONOPOLAR HOOK (BLUE PART) WAS MELTED. ROOT CAUSE ANALYSIS: AFTER INVESTIGATION, THERE WAS NO MANUFACTURING OR COATING DEFECT FOUND ON THE HOOK. IT IS DETERMINED THAT THE EVENT MAY BE DUE TO A DEFECT OF THE COATING BEFORE THE SURGERY OR THE USE OF TOO OF HIGH OF VOLTAGE. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE INSTRUMENT CLEARLY WARNS OF THE MAXIMAL ASSIGNED OUTPUT VOLTAGE THAT CAN BE APPLIED TO A MONOPOLAR HIGH-FREQUENCY ELECTROSURGICAL ACCESSORY, IN ADDITION TO EXCEPTIONS FOR SPECIAL INDICATIONS ETCHED ON THE INSTRUMENT AND/OR ON A SPECIFIC INSERT. "SUCH PEAK VOLTAGE CAN BE ACHIEVED WITH CERTAIN MODES OF FUNCTIONING OF SOME ELECTROSURGICAL GENERATORS. PLEASE CHECK WITH THE MANUFACTURER OF THE ELECTROSURGICAL GENERATOR AND/OR REFER TO THE TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER OF THE ELECTROSURGICAL GENERATOR".

    Additional Manufacturer Narrative · 0

    ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THERE WAS NO CONSEQUENCE OR INJURY TO THE PATIENT AND NO INCREASE IN SURGERY TIME OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE USER AVOIDED AS MUCH AS POSSIBLE, DROPPING MELTED PIECES INTO THE OPERATING FIELD. THE SURGERY WAS FINISHED WITHOUT THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE SHEATH OF THE HOOK 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED IN THE PATIENT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231547 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S. 5646280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown