BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC TROCAR SLEEVE

    MDR report key: 9386 · Received August 5, 1994

    Report

    Report Number
    1418479-1994-09065
    Event Type
    Malfunction
    Date Received
    August 5, 1994
    Date of Event
    July 11, 1994
    Report Date
    July 22, 1994
    Manufacturer
    R WOLF, GMBH
    Product Code
    FBQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, A SMALL SECTION OF FIBERGLASS MATERIAL BROKE OFF OF THE TIP. THE FRAGMENT WAS RETRIEVED FROM THE PT'S ABDOMEN. NO OTHER PROBLEMS WERE REPORTED. THE PIECE WAS DISCARDED BY THE USER FACILITY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC TROCAR SLEEVE SAME FBQ R WOLF, GMBH 8351.07 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other