BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH PNEUMOPERITONEUM NEEDLE

    MDR report key: 52220 · Received November 27, 1996

    Report

    Report Number
    1218017-1996-00042
    Event Type
    Injury
    Date Received
    November 27, 1996
    Date of Event
    November 1, 1996
    Report Date
    November 26, 1996
    Manufacturer
    LACEY MFG CO.
    Product Code
    FHP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: STYLET FOUND TO BE WITHIN DESIGN SPECIFICATIONS. RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT DURING SURGERY. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION AND THE STYLET WAS FREE OF OCCLUSIONS. THE NEEDLE WAS TESTED AND FUNCTIONED AS DESIGNED. THE STYLET WAS FOUND TO OPERATE SMOOTHLY AND WITHOUT BINDING. IT WAS CONCLUDED THAT THE NEEDLE WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE CUSTOMER REPORTED COULD NOT BE REPEATED. EACH INSTRUMENTS IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TUBAL LIGATION, THE SURGEON INSERTED THE VERESS NEEDLE. HE EXPERIENCED DIFFICULTY ESTABLISHING PNEUMOPERITONEUM. HE INSERTED THE TROCARS AND HAD THE SAME DIFFICULTY. HE COULD NOT GET THE INSUFFLATOR TO MAINTAIN PNEUMOPERITONEUM. THE DECISION WAS MADE TO CONVERT TO OPEN TO COMPLETE THE DEVICE, THE TUBING, THE VERESS NEEDLE, OR THE TROCARS. THE SURGEON THINKS THE PROBLEM MAY BE DUE TO THE INSUFFLATOR AND IT IS BEING ANALYZED BY THE HOSP. THE PT WAS EXTREMELY HEAVY. THE PNEUMO NEEDLE AND THE TROCARS ARE BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH PNEUMOPERITONEUM NEEDLE PNEUMOPERITONEUM NEEDLE FHP LACEY MFG CO. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention