BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH TROCAR SHEATH

    MDR report key: 9860 · Received February 4, 1994

    Report

    Report Number
    9860
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    August 20, 1993
    Report Date
    August 20, 1993
    Manufacturer
    ETHICON
    Product Code
    FBQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TIP OF SHEATH BROKE OFF INSIDE OF PATIENT'S ABDOMEN DURING LAPAROSCOPIC TUBAL LIGATION. X-RAY TAKEN IN O.R. LAPAROSTOMY PERFORMED AND TIP FOUND AND REMOVED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH TROCAR SHEATH FBQ ETHICON TS111 EE5671

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention