BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 121889 · Received September 19, 1997

    Report

    Report Number
    2939738-1997-00032
    Event Type
    Malfunction
    Date Received
    September 19, 1997
    Report Date
    August 20, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUMMARIES ARE THE FINAL RESULTS OF THIS INVESTIGATION. THIS FOLLOW-UP COVERS BOTH OF THE DEVICES ALLEGEDLY REPORTED TO HAVE MALFUNCTIONED. OBSERVATION ON FAILURE: CUSTOMER HAS CLAIMED THAT THE TIP DID NOT RETRACT IN THE RETURNED UNIT. THE RETURNED PRODUCT COULD NOT BE DUPLICATED FOR THE FAILURE AFTER MORE THAN 50 CYCLES WHILE INSERTING THROUGH "PINK FOAM" USED TO SIMULATE USAGE CONDITIONS. THE BOND BETWEEN THE LATCH AND THE SEAL TUBE WAS CRACKED. ALTHOUGH THE BOND WAS CRACKED, THE UNIT STILL FUNCTIONED PROPERLY WITHOUT ANY PROBLEM. CAUSE OF FAILURE: THE CAUSE OF THE ALLEGED FAILURE CANNOT BE DETERMINED FROM THE RETURNED PRODUCT. THE PRODUCT WORKED AS EXPECTED. LONG TERM CORRECTIVE ACTION: NO ACTION CAN BE TAKEN AT THIS TIME. THE FAILURE CANNOT BE DUPLICATED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SENSING TIP TROCAR AND OBTURATOR ALLEGEDLY FAILED TO RETRACT. THE PT DIDN'T SUFFER ANY CONSEQUENCE DUE TO THE ALLEGED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP OBTURATOR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T10SO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN