BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTUBE FOR LIGATOR

    MDR report key: 8420 · Received February 8, 1994

    Report

    Report Number
    1223688-1994-09001
    Event Type
    Injury
    Date Received
    February 8, 1994
    Date of Event
    December 1, 1993
    Report Date
    January 19, 1994
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Product Code
    MND
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN STATES THAT A 50 YEAR OLD FEMALE PRESENTED FOR ESOPHAGAEAL LIGATION ON 12/1/93. THE PT HAD PREVIOUSLY HAD SEVERAL SCLEEEEEROTHERAPY TREATMENTS. THE PHYSICIAN PLACED THE OVERTUBE COAXIALLY WITH A 44F DILATOR AND HAD DIFFICULTY POSITIONING THE TUBE. THE PT'S HEAD WAS TILTED AND INTUBATION WAS COMPLETED. AAAFTER THE BANDING PROCEDURE, THE PHYSCIAN NOTED ENDOSCOPICALLY, A 2-3 CM POUCH AS HE WITHDREW THE SCOPE. BECAUSE OF THE DIFFICULTY PLACING THE OVERTUBE, A CONTRAST STUDY OF THE ESOPHAGUS WAS PERFORMED ANAD A SMALL ESOPHAGEAL TEAR WAS NOTED. THE PT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE TEAR WAS SURGICALLY REPAIRED. THE PT WAS DISCHARGED WITHIN A WEEK AND NO FURTHER COMPLICATIONS WERE REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.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 OVERTUBE FOR LIGATOR MND SUPERIOR HEALTH CARE GROUP, INC. 200219

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention