BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 82045 · Received February 20, 1997

    Report

    Report Number
    9680598-1997-00025
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6;H4: INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT OR BATCH ID. RESULTS OF EVALUATION: CONCLUSION: BASED ON THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT IT WAS THE INNER GASKET THAT HAD BECOME DISLODGED (IT WAS RECEIVED IN A SEALED POUCH). NO CONCLUSION COULD BE REACHED AS TO HOW THE GASKET BECAME DISLODGED.

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE THE WHITE SEAL FOR THE 45 DEGREE FLAPPER VALVE FELL INTO THE ABDOMEN. THERE WAS NO CONSEQUENCE TO THE PT. 1/27/97. ANOTHER TROCAR WAS NOT NEEDED TO COMPLETE THE CASE. THE SEAL WAS RETRIEVED LAPAROSCOPICALLY. CLINICAL FOLLOW UP. 1/27/97 1515 OFFICE CLOSED FOR LUNCH. 1/27/97 1620 MESSAGE AND 800 # LEFT FOR SURGEON TO CALL BACK. 1/28/97 1350 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ EES-JUAREZ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other