BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM2000 ELECTROSURG.

    MDR report key: 8065792 · Received November 13, 2018

    Report

    Report Number
    1216677-2018-00062
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    August 2, 2018
    Report Date
    November 30, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-REVIEW DHR X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS NO SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. THE COMPLAINT WAS NOT DUPLICATED WITH THE UNIT. BASED ON THE INFORMATION PROVIDED, THE SPECULUM (P/N 903018) WAS DETERMINED TO HAVE A COMPROMISED COATING. THE COATING CAN BE REDUCED FROM EXCESSIVE RUBBING THEREBY MORE PRONE TO PRODUCING A SHOCK. THE CLEANING/STERILIZATION ITSELF IS NOT THOUGHT TO AFFECT THE COATING BUT THE MECHANICAL ACTION OF SCRUBBING AFTER CLEANING/STERILIZATION CAN. IT ISN'T TYPICAL TO HAVE TO SCRUB A SPECULUM. A DEFINITIVE ROOT CAUSE IS NOT AVAILABLE, BUT THE SPECULUM WAS DETERMINED TO BE INADVERTENTLY COMPROMISED BY THE STERILIZATION/CLEANING PROCESS THE CUSTOMER HAD USED. THE IFU INSTRUCTS THE USE OF NON-CONDUCTIVE ANCILLARY INSTRUMENTS. DUE TO THE COMPROMISED COATING THIS WAS NOT FOLLOWED AND MISSED BY THE CUSTOMER. THIS COMPLAINT IS BEING ATTRIBUTED TO END USER ERROR. ALL SPECULUM UNITS, P/N 903018, ARE 100% INSPECTED (DIELECTRIC TESTING) WHEN RECEIVED IN FROM THE VENDOR PRIOR TO ACCEPTING INTO CSI'S TRUMBULL FACILITY FOR SHIPMENTS. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS CHECKED OUT AND RETURNED TO THE CUSTOMER. NO REPAIRS WERE REQUIRED. THE VENDOR WAS INFORMED OF THE SPECULUM BEING THE CONTRIBUTING FACTOR FOR THIS COMPLAINT. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    REFERENCE REPAIR ORDER: (B)(4). "CUSTOMER STATED "PATIENT SAFETY, ISSUE, PATIENT SHOCKED". REF. E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REFERENCE REPAIR ORDER: (B)(4). "CUSTOMER STATED "PATIENT SAFETY, ISSUE, PATIENT SHOCKED". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905691 QUANTUM2000 ELECTROSURG. QUANTUM2000 ELECTROSURG. HGI COOPERSURGICAL, INC. 909075 N/A

    Patients

    Seq Age Sex Outcome Treatment
    0 Other
    1 Unknown Other| O