BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 159232 · Received March 24, 1998

    Report

    Report Number
    1519132-1998-00005
    Event Type
    Injury
    Date Received
    March 24, 1998
    Date of Event
    November 4, 1997
    Report Date
    November 4, 1997
    Manufacturer
    CIRCON OHIO OFFICE
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A PHOTOGRAPH OF THE DEVICE THAT SHOWS THE BODY OF A TIP AND THE END OF THE TIP THAT HAS SEPARATED WAS PROVIDED TO THE INTITIAL REPORTER BY THE CHIEF COUNSEL INDICATED THE INDENTIFICATION OF THE MODEL NUMBER AND CATALOG NUMBER OF THE DEVICE. THAT INFO IS PROVIDED BELOW. PLEASE NOTE THAT THE DEVICE HS NOT BEEN RETURNED TO CIRCON FOR IDENTIFICATION OR EVALUATION. CABOT MEDICAL CORP, LANGHORNE, PA PURCHASED THE CRYOSURGICAL PRODUCT LINE FROM CRYOMEDICS, TRUMBULL, CT, IN MID-1987. AFTER THE MERGER OF CABOT MEDICAL WITH CIRCON CORP, THE CIRCON CABOT FACILITY WAS CLOSED IN 11/1996. SINCE CRYOTIPS ARE NOW MFG BY CIRCON OHIO OFFICE, NORWALK, OH, THE ESTABLISHMENT REGISTRATION NUMBER FOR THAT FACILITY HAS BEEN USED FOR THIS REPORT. AS A RESULT OF FOUR COMPLAINTS OF TIP LEAKAGE (NOT TIP SEPARATION) FILED IN LATE 1987 AND EARLY 1988, CABOT MEDICAL INVESTIGATED CAUSES OF DETERIORATION OF THE SILVER BRAZE JOINT OF THE CRYOTIPS AND EVALUATED THE MFG PROCESS. IN 9/1998, THE MFG PROCESS WAS REVISED TO PREVENT INCOMPLETE BONDING, THE MFG PROCEDURE WAS CHANGED SO THAT THE OPERATOR COULD VISUALLY VERIFY THAT BRAZE FILLED THE ENTIRE JOINT. A PRE-FORM OF BRAZE IS PLACED INSIDE THE JOINT IN THE COUNTER BORE OF THE SILVER TIP. THE EXTENSION ROD IS PLACED OVER THE SILVER TIP, THE JOINT IS HEATED AND BRAZE FLOWS OUT THE JOINT INDICATING THAT THE JOINT IS COMPLETELY FILLED. THE JOINT IS THEN TESTED AT 3000 PSI FOR 20 TO 25 CYCLES TO CONFIRM THE INTEGRITY OF THE JOINT. TO FURTHER IMPROVE THE STRENGTH OF THE BOND, IN 9/1998, THE BRAZE WAS CHANGED TO ONE THAT HELPS AVOID INTERFACE CORROSION. IN6/1995, CABOT MEDICAL CORP MAILED A LETTER TO ALL CUSTOMERS WHO PURCHASED A CRYOSURGICAL PRODUCT FROM CABOT MEDICAL. IN THE LETTER, IT WAS RECOMMENDED THAT ALL TIPS PURCHASED PRIOR TO 1989 BE REPLACED. ACCORDING TO THE INTITIAL LETTER RECEIVED FROM THE ATTORNEY, THE INCIDENT OCCURRED, FL. A SEARCH OF THE SHIPPING RECORDS SHOWS THAT THE MOST RECENT SHIPMENT OF CRYOTIPS TO THAT FACLILITY OCCURRED ON 6/23/1988. IT IS NOT KNOWN IF THE CRYOTIP ASSOCIATED WITH THIS INCIDENT WAS MFG BY CRYOMEDICS OR CABOT MEDICAL CORP.

    Description of Event or Problem · 1

    ACCORDING TO A LETTER RECEIVED FROM AN ATTORNEY, A PT SUSTAINED INJURIES WHEN UNDERGOING CRYOTHERAPY. A CRYOPROBE WAS INSERTED INTO THE VAGINAL CANAL AND THE NITROGEN GAS WAS TURNED ON. AT THAT MOMENT THE CRYOWAND EXPLODED AND SHOT THE METAL PROBE TIP INTO THE PT, ALLOWING THE NITROGEN GAS TO FREEZE HER ORGANS. THE ATTORNEY STATED THAT AS A RESULT OF THE INCIDENT THE PT HAS UNDERGONE A HYSTERECTOMY AND IT HAS ALSO BEEN DETERMINED THAT SHE HAS SUSTAINED A PERMANENT INJURY TO HER BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CRYOSURGICAL UNIT GEH CIRCON OHIO OFFICE T-0823 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization