BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARD WOLF MEDICAL INSTRUMENTS "CARBON DIOXIDE INSUFFLATOR

    MDR report key: 3398 · Received July 30, 1992

    Report

    Report Number
    3398
    Event Type
    Injury
    Date Received
    July 30, 1992
    Date of Event
    June 8, 1992
    Report Date
    July 28, 1992
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HES
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEVICES USED AS REQUESTED IN #34; DYONICS-DYO CAM 750 CAMERA, CATALOG #3945, SERIAL NO. 7D-1284; DYONICS-ABI-II ILLUMINATOR-LIGHT SOURCE, CATALOG #3180, SERIAL NO. 1635; YAG LASER, SURGICAL LASER TECHNOLIGIES, CATALOG #CL-60, SERIAL NO. 88031712, MFRD 12/88.EVENT DESCRIPTION: SEE BELOWPATIENT UNDERWENT LAPAROSCOPY ON 6/8/92 FOLLOWING HYSTEROSCOPY. AT APPROXIMATELY 1 HOUR INTO THIS 1 HOUR 45 MINUTE PROCEDURE, THE ANESTHESIOLOGIST NOTIECED THE PATIENT WAS DEVELOPING SUBCUTANEOUS EMPHYSEMA. THE INSUFFLATOR HAD BEEN SET ON "AUTOMATIC" WHICH, ACCORDING TO THE MANUFACTURER'S OPERATING INSTRUCTIONS, WILL LIMIT GAS FLOW TO A MAXIMUM INTRA ABDOMINAL PRESSURE OF 14MM HG. THE READING ON THE INTRA ABDOMINAL PRESSURE GAUGE READ ABOVE 50MM HG. THE INSUFFLATOR WAS SHUT OFF AND CARBON DIOXIDE WAS ALLOWED TO ESCAPE FROMT HE ABDOMEN.FOLLOWING THE PROCEDURE THE PATIENT WAS ADMITTED FOR OVERNIGHT EVALUATION AND A PULMONARY SPECIALIST WAS ASKED TO CONSULT. X-RAYS WERE ORDERED WHICH SHOWED A LARGE LEFT SIDED PNEUMOTHORAX, FREE INTRAPERITONEAL AIR AND EXTENSIVE SUBCUTANEOUS EMPHYSEMA PRESENT OVER THE THORAX AND NECT. ON 6/10/92 IT WAS NECESSARY TO PERFORM A TUBE THORACOSTOMY TO HELP EXPAND THE LEFT LUNG. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 6/12/92 IN STABLE CONDITION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MEDICAL INSTRUMENTS "CARBON DIOXIDE INSUFFLATOR N/A HES RICHARD WOLF MEDICAL INSTRUMENTS CORP. E2026.60 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention