BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDH #29

    MDR report key: 3555 · Received December 30, 1992

    Report

    Report Number
    3555
    Event Type
    Malfunction
    Date Received
    December 30, 1992
    Date of Event
    October 27, 1992
    Report Date
    December 10, 1992
    Manufacturer
    ETHICON
    Product Code
    FHM
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    5O YEAR OLD ADMITTED FOR LOW ANTERIOR RESECTION FOR CA. ETHICON CDH 29 CURVED INTRALUMINAL STAPLER WAS INTRODUCED VIA THE RECTUM BY THE SURGEON UNDER DIRECTION OF THE SALES REP. AS THE INSTRUMENT WAS TWISTED, AS DIRECTED, AS DIRECTED, THE CONE TIP PERFORATED THE POSTERIOR WALL OF THE BOWEL. THE INSTRUMENT WAS REMOVED AND TAKEN BY THE REP. A HAND SEWN ANASTAMOSIS WAS DONE. PATIENT DISCHARGED HOME AFTER A SEVEN DAY LENGTH OF STAYINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDH #29 FHM ETHICON CL3ON

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other