BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC TROCAR SLEEVE W/CLIP VALVE

    MDR report key: 7105 · Received November 10, 1993

    Report

    Report Number
    1418479-1993-09002
    Event Type
    Malfunction
    Date Received
    November 10, 1993
    Date of Event
    August 23, 1993
    Report Date
    September 15, 1993
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FBQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, A SMALL SECTION OF MATERIAL BROKE OFF OF THE FIBERGLASS TIP. TWO (2) PIECES APPROX. 1 X 10 MM EACH WERE RETREIVED FROM PATIENT'S ABDOMEN. NO OTHER PROBLEMS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC TROCAR SLEEVE W/CLIP VALVE LAPAROSCOPIC TROCAR SLEEVE FBQ RICHARD WOLF GMBH 8351.07 M-F-R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other