BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF-RESECTION ELECTRODE, LOOP

    MDR report key: 17046789 · Received June 2, 2023

    Report

    Report Number
    9610773-2023-01508
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 11, 2023
    Report Date
    June 29, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761068236
    PMA / PMN Number
    K120418
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING AND QUALITY RECORDS FOR THE AFFECTED LOT NUMBER WAS REVIEWED WITHOUT DETECTING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. ADDITIONAL 510(K): K100275.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: B1, B2, B5, D8, E1, H1, H3 AND H6. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER/SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. THE RESULT OF OUR INVESTIGATION IS CONSISTENT WITH THE CUSTOMER'S DESCRIPTION OF FAILURE. THE CUSTOMER REPORTS THAT THE ELECTRODE IS ¿CUT IN TWO¿. DURING INVESTIGATION, OLYMPUS IDENTIFIES THAT THE LOOP OF THE ELECTRODE IS BROKEN AND THE ENDS OF THE WIRE ARE MELT DOWN. ADDITIONALLY, THE FORK OF THE ELECTRODE IS DEFORMED. BASED ON THE BURN MARKS AND SIGNS OF THERMAL STRESS, OLYMPUS ASSUMES THAT THE ELECTRODE LOOP HAS BEEN CLEARLY DEFORMED DURING THE REPORTED INCIDENT. NO ERROR MESSAGE OF THE GENERATOR IS REPORTED. THE CAUSE IS VERY LIKELY IMPROPER HANDLING/EXCESSIVE FORCE BY THE USER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING AN ENDOMETRIAL HYSTERECTOMY, THE SURGEON FOUND THE LOOP WIRE OF THE HIGH FREQUENCY RESECTION ELECTRODE WAS CUT IN TWO. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. ALTHOUGH THERE WAS A DELAY OF INTERVENTION AND INCREASE OF ANESTHESIA TIME FOR THE OBESE PATIENT, NO PATIENT INJURY WAS CONFIRMED.

    Description of Event or Problem · 0

    OLYMPUS FURTHER RECEIVED INFORMATION THAT THE PIECE OF THE DEVICE WAS RECOVERED FROM THE PATIENT'S BODY. THE OPERATING MODE WAS BIPOLAR IN SALINE. THERE WAS A FIFTEEN-MINUTE PROCEDURE DELAY. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289485 HF-RESECTION ELECTRODE, LOOP ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22507D 1000105911 14042761068236

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention