BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUROHEALTH LARGE ORGAN RETRACTOR

    MDR report key: 75079 · Received March 5, 1997

    Report

    Report Number
    1527736-1997-01001
    Event Type
    Malfunction
    Date Received
    March 5, 1997
    Date of Event
    February 3, 1997
    Report Date
    March 4, 1997
    Manufacturer
    EUROHEALTH SYSTEMS
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6;H4: INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT OR BATCH ID. VISUAL INSPECTIONS & RESULTS: BULLET TIP CONDITION; NA. DESUFFLATION LEVER CONDITION, AND INNER GASKET CONDITION; CONFORMING. OBTURATOR CONDITION; NA. OUTER GASKET CONDITION; NOT CONFORMING. RESET BUTTON CONDITION; NA. SLEEVE CONDITION; CONFORMING. STOPCOCK CONDITION; CLOSED. TROCAR CONDITION; NA. FUNCTIONAL TESTS & RESULTS: FLAPPER DOOR FUNCTIONAL; CONFORMING. LOCKOUT FUNCTIONAL; NA. ANALYSIS CONCLUSION: BASED ON THE VISUAL EXAMINATION IT WAS CONFIRMED THE OUTER GASKET WAS TORN. NO CONCLUSION COULD BE REACHED AS TO HOW THE OUTER GASKET BECAME TORN.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION AFTER FOUR HRS IN A DIFFICULT CASE WITH A LARGE PT, THE LOR12 PADDLE WAS OBSERVED TO BE FLAT. WHEN MORE SALINE WAS INSTILLED INTO THE INSTRUMENT, IT WAS OBSERVED THE PADDLE HAD SEPARATED FROM THE SHAFT AND FELL INTO THE PT. THE PADDLE WAS RETRIEVED WITHOUT INCIDENT. ANOTHER LOR12 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 2/4/97 1600 SURGEON RETURNED THE CALL AND STATED THE DEVICE CAME APART AND THE FAN PORTION FELL INTO THE PT. HE WAS ABLE TO RECOVER THAT PORTION FROM WITHIN THE PT AND A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. HE SAID THERE WAS NO SOUND OR TACTILE FEELING WHEN THE DEVICE CAME APART. HE STATED THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUROHEALTH LARGE ORGAN RETRACTOR LARGE ORGAN RETRACTOR KNS EUROHEALTH SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other