BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADSON BIPOLAR FORCEPS 4-3/4 1MM TIP

    MDR report key: 11882736 · Received May 26, 2021

    Report

    Report Number
    2523190-2021-00106
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 29, 2021
    Report Date
    January 25, 2022
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GEI
    PMA / PMN Number
    PREAMENDMENT
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10 THE RB9221 ADSON BIPOLAR FORCEPS WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF PATIENT BURN MAY BE THE RESULT OF ACCIDENTAL CONTACT WITH THE ELECTRICAL END OF THE FORCEPS TIPS. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE ADSON BIPOLAR FORCEPS (RB9221) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE FORCEPS WERE RECEIVED IN USED CONDITION WITH NO VISIBLE DEFECT. THE FORCEPS FUNCTIONED AS INTENDED AND NO DAMAGE WAS IDENTIFIED DURING INSULATION TESTING. ROOT CAUSE ANALYSIS: THE ISSUE OF BURNING THE PATIENT'S NOSE MAY HAVE BEEN THE RESULT OF UNINTENTIONAL ACTIVATION OR ACCIDENTAL CONTACT. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT DURING AN ENT PROCEDURE, THE ADSON BIPOLAR FORCEPS (RB9221) ALLOWED CURRENT TO FLOW ALL THE WAY TO THE TIP CAUSING A SLIGHT SUPERFICIAL BURN INSIDE THE PATIENT'S NOSE. ANTIBIOTIC CREAM WAS APPLIED TO THE PATIENT'S BURNED NOSE AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779120 ADSON BIPOLAR FORCEPS 4-3/4 1MM TIP BIPOLAR FORCEPS GEI INTEGRA YORK, PA INC. 0287

    Patients

    Seq Age Sex Outcome Treatment
    1 Male