BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACO SURE TOUCH HANDPIECE

    MDR report key: 17780393 · Received September 20, 2023

    Report

    Report Number
    1222074-2023-00065
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 15, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, ONE SURETOUCH PHACO HANDPIECE WAS RETURNED FOR INVESTIGATION. RIGOROUS TESTING REVEALED THAT THE COMPROMISED FUNCTIONALITY OF THE HANDPIECE WAS THE RESULT OF A SHORT CIRCUIT IN THE TRANSDUCER. THE SHORT CIRCUIT ITSELF WAS MOST LIKELY CAUSED BY WATER INGRESS DUE TO A FAILING SEAL. SHORT CIRCUITS DUE TO WATER INGRESS ARE A KNOWN ISSUE WITH THIS PRODUCT AND ARE THEREFORE CONSIDERED AN EXPECTED CONSEQUENCE OF NORMAL WEAR AND TEAR AFTER REPEATED USE AND REPROCESSING (I.E., CLEANING AND STERILIZATION); HOWEVER, IN ORDER TO PREVENT THIS FAILURE IN RELATIVELY YOUNG HANDPIECES SUCH AS THE ONE INVOLVED IN THIS CASE, CORRECTIVE ACTIONS IN TERMS OF A MORE ROBUST SEAL TO IMPROVE RESISTANCE AGAINST WATER INGRESS HAVE BEEN IMPLEMENTED. WE HAVE BEEN INFORMED THAT IN HINDSIGHT, THE EVENT DID NOT OCCUR DURING SURGERY AND THEREFOR SURGERY WAS NOT PROLONGED. THEREFORE, THE INCIDENT IS ASSESSED AS NOT REPORTABLE.WE HAVE BEEN INFORMED THAT IN HINDSIGHT, THE EVENT DID NOT OCCUR DURING SURGERY AND THEREFOR SURGERY WAS NOT PROLONGED.THEREFORE, THE INCIDENT IS ASSESSED AS NOT REPORTABLE. IN ORDER TO PREVENT THIS FAILURE IN RELATIVELY YOUNG HANDPIECES SUCH AS THE ONE INVOLVED IN THIS CASE, CORRECTIVE ACTIONS IN TERMS OF A MORE ROBUST SEAL TO IMPROVE RESISTANCE AGAINST WATER INGRESS WERE IMPLEMENTED AS PART OF DTP 2021-324

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE, OR TRY TO REPLICATE THE PROBLEM ON SIMILAR PRODUCT.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PHACO SURGERY, THE ULTRASOUND FUNCTION SUDDENLY FAILS WHEN THE SURETOUCH HANDLE IS USED, AND THE BODY OF THE SURETOUCH HANDLE IS TOO HOT TO USE. THE SURGERY WAS COMPLETED WITH ANOTHER PACK OF THE SAME TYPE. SURGERY WAS PROLONGED > 30 MIN. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED. WE HAVE BEEN INFORMED THAT IN HINDSIGHT, THE EVENT DID NOT OCCUR DURING SURGERY; NO PROLONGED SURGERY TOOK PLACE. THEREFORE, THE INCIDENT IS ASSESSED AS NOT REPORTABLE.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PHACO SURGERY, THE ULTRASOUND FUNCTION SUDDENLY FAILS WHEN THE SUPER BREAST HANDLE IS USED, AND THE BODY OF THE SUPER BREAST HANDLE IS TOO HOT TO USE. THE SURGERY WAS COMPLETED WITH ANOTHER PACK OF THE SAME TYPE. SURGERY WAS PROLONGED > 30 MIN. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801053 PHACO SURE TOUCH HANDPIECE PHACOEMULSIFICATION SYSTEM HANDPIECE HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown