BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAT PROBE

    MDR report key: 3202 · Received July 6, 1992

    Report

    Report Number
    3202
    Event Type
    Injury
    Date Received
    July 6, 1992
    Date of Event
    February 21, 1992
    Report Date
    March 17, 1992
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    EXX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 2/21/92, A SIXTY-TWO YEAR OLD FEMALE WAS ADMITTED FOR ENDOSCOPIC MANAGEMENT OF RECTAL BLEEDING. THE PATIENT'S MEDICAL HISTORY INCLUDED DIVERTICULOSIS AND CECAL ANGIODYSPLASIA. UNDEE IV-CONCIOUS SEDATION, HEATER-PROBE COAGULATION WITH OLYMPUS HPU HEALT PROBE UNIT AND OLYMPUS CD HEAT PROBE OF FIVE (5) ARTERIOVENOUS MALFORMATIONS IN THE CECUM, AND EXCISION VIA CAUTERY SNARE OF AN EIGHT (8MM) SIGMOID POLYP WERE PERFORMED. THE PROCEDURE WAS ATRAUMATIC AND THE PATIENT TOLERATED IT WELL. SHE WAS DISCHARGED IN STABLE CONDITION APPROXIMATELY THREE HOURS LATER.THE FOLLOWING DAY, THE PATIENT EXPERIENCED SUDDEN SPREADING PELVIC-VAGINAL PAIN AND AFTER READMISSION TO THE HOSPITAL, SHE WAS TRANSFERRED TO THE OPERATING ROOM. EXPLORATORY LAPAROTOMY, ABDOMINAL LAVAGE AND SUTURE IMBRICATIONS OF CECAL PERFORATIONS WERE PERFORMED.IN CONCLUSION, SPECIFIC CAUSE FOR THIS OCCURRENCE IS UNKNOWN. NO EQUIPMENT DEFECT/MALFUNCTION OR DIVIATION FROM STANDARD PRACTICE OF PATIENT CARE RENDERED BY PHYSICIAN OR HOSPITAL STAFF WERE FOUND TO HAVE OCCURRED. AT THE RESENT TIME, THE PATIENT IS STABLE AND RECUPERATING AT HOME, HAVING BEED DISCHARGED ON THE THIRTEENTH POST-OPERATIVE DAYDEVICE 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-FEB-92. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS NOT 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAT PROBE HAT PROBE CATHETER FOR REGULAR CHANNEL EXX OLYMPUS CORPORATION CD-20Z UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention