BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRIPSY PROBE 1.9FR 375CM DS

    MDR report key: 11605803 · Received April 1, 2021

    Report

    Report Number
    0001450997-2021-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 1, 2021
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NORTHGATE TECHNOLOGIES RECEIVED NOTIFICATION FROM A DISTRIBUTOR ON MARCH 02, 2021 OF THE ALLEGED EVENT. THERE WAS NO ADVERSE IMPACT TO THE PATIENT INVOLVED IN THE PROCEDURE OTHER THAN A MINOR DELAY TO SWITCH OUT THE PROBE THAT MALFUNCTIONED WITH ANOTHER PROBE. NORTHGATE ATTEMPTED TO OBTAIN FURTHER INFORMATION ABOUT THE SEVERITY OF THE INJURY TO THE NURSE, USE OF THE DEVICE, AND TO REQUEST THE DEVICE BE SENT IN FOR EVALUATION. CAPA (B)(4) WAS INITIATED TO INVESTIGATE THE ALLEGED EVENT. ON 3/23/2021, NTI WAS INFORMED THAT THE PROBE INVOLVED IN THE EVENT WAS DISPOSED OF AFTER THE PROCEDURE AND THEREFORE WAS NOT AVAILABLE FOR INVESTIGATION. ADDITIONALLY, NTI WAS INFORMED THAT THE NURSE WENT TO SEE THE DOCTOR AS A PRECAUTIONARY MEASURE AND THEY INDICATED THAT THE NURSE HAD 3 BURN SPOTS ON HER EYE AND THAT SHE DOES NOT HAVE ANY SERIOUS DISCOMFORT OR ANY VISION ISSUES. THE INVESTIGATION WILL PROCEED, ANY ADDITIONAL FINDINGS WILL BE UPDATED VIA A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING EVENT " THE SPYGLASS WAS PASSED INTO THE PATIENTS BILE DUCT AND THE STONE WAS VISUALIZED THROUGH SPYGLASS. THE EHL PROBE WAS OPENED AND PASSED DOWN THE WORKING CHANNEL OF THE SPYSCOPE. IT WAS CONNECTED TO THE GENERATOR PROPERLY. ONCE THE PHYSICIAN WENT TO STEP ON THE GENERATOR PEDAL THE PROBE SPARKED AND ZAPPED NEAR THE CONNECTION OF THE PROBE END TO THE GENERATOR AS THE NURSE WAS HOLDING IT. IT WAS LATER COMMUNICATED TO ME THAT THE NURSE HAD GOTTEN SOMETHING IN [REDACTED THE] EYE AND THE LAB WAS SENDING [REDACTED NURSE] TO GET [REDACTED THEIR] EYES CHECKED. I WAS LATER TOLD THEY FOUND 3 BURN SPOTS ON [REDACTED NURSE'S] EYE AND THEY ARE SENDING [REDACTED NURSE] TO THE DOCTOR." AFTER FURTHER FOLLOW UP WITH THE INITIAL REPORTER IT WAS INDICATED THAT THE NURSE "WENT TO SEE A DOCTOR [REDACTED] AS A PRECAUTIONARY MEASURE. THEY INDICATED THAT [REDACTED NURSE] HAD 3 BURN SPOTS ON [REDACTED THEIR] EYE. WHILE [REDACTED NURSE] DOES NOT HAVE ANY SERIOUS DISCOMFORT AOR ANY VISION ISSUES [REDACTED NURSE] WANTED IT REPORTED AND WANTS TO MAKE SURE WE REPORTED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503364 LITHOTRIPSY PROBE 1.9FR 375CM DS INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 BSC14944 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 Other