BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2226915 · Received August 23, 2011

    Report

    Report Number
    9610617-2011-00035
    Event Type
    Other
    Date Received
    August 23, 2011
    Date of Event
    December 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY CENTER HAD 1 OF THESE SCOPES; IT WAS NOT RETURNED AS A RESULT OF THESE EVENTS BUT WAS IN FOR SERVICE ON (B)(4) 2010, FOR BEING FLOODED; IT WAS CONSIDERED IRREPARABLE AND CUSTOMER HAD IT RETURNED AS IS (UNREPAIRED). THE PATIENT DID NOT REPORT ANY MALFUNCTION OF THE VIDEO CYSTOSCOPE. I CALLED (B)(6), WHERE THE 3 PROCEDURES TOOK PLACE AND LEARNED THAT THE DOCTOR WHO PERFORMED PROCEDURES WAS NO LONGER AFFILIATED WITH THEIR CENTER AND THEY WERE NOT PERFORMING THIS PROCEDURE AT THIS TIME. WE SUSPECT FROM PAST REPORTS OF THIS ISSUE THAT THE SURGERY SITE MAY HAVE BEEN USING CIDEX OPA FOR HIGH LEVEL DISINFECTANT CLEANING OF SCOPE; CIDEX OPA IS CONTRAINDICATED FOR USE WITH BLADDER CANCER PATIENTS. THE MSDS FOR THIS PRODUCT STATES: "CIDEX OPA SOLUTION HAS BEEN REPORTED TO CAUSE ANAPHYLACTIC-LIKE REACTIONS IN BLADDER CANCER PATIENTS UNDERGOING REPEATED CYSTOSCOPY. CIDEX OPA SOLUTION SHOULD NOT BE USED TO REPROCESS INSTRUMENTS FOR PATIENTS THAT HAVE SHOWN PREVIOUS SENSITIVITY TO THIS SOLUTION OR ANY OF ITS INGREDIENTS." OUR CLEANING INSTRUCTIONS ALSO PROVIDE THIS WARNING: "WARNING: REFER TO CIDEX OPA LABELING FOR IMPORTANT CONTRAINDICATIONS REGARDING THE USE OF CIDEX OPA ON INSTRUMENTS THAT WILL BE USED FOR PATIENTS WITH BLADDER CANCER." I FORWARDED MSDS TO (B)(6) AND PATIENT.

    Description of Event or Problem · 1

    PATIENT STATED THAT HE HAS HAD 3 CYSTOSCOPIES FOR POST-BLADDER CANCER TREATMENT ((B)(6) 2010, (B)(6) 2011) AFTER WHICH AND DURING HE EXPERIENCED AN ALLERGIC REACTION. ON THE FIRST TWO, ALMOST IMMEDIATELY AFTER PROCEDURE, HE HAD REDNESS OF FACE AND SKIN BLOTCHES; ON THE 3RD ONE HE HAD DIFFICULTY BREATHING ALONG WITH OTHER SYMPTOMS WHILE HE WAS STILL ON TABLE. HE WAS ADMITTED TO EMERGENCY ROOM ON ALL 3 OCCASIONS. EMERGENCY ROOM ADMINISTERED EPINEPHRINE TO ADDRESS ALLERGIC SYMPTOMS; ALLERGIC REACTION CEASED WHEN MEDICATION TOOK HOLD. HE WAS TREATED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ FLEXIBLE VIDEO CYSTOSCOPE FAJ KARL STORZ GMBH & CO. KG 11272VNU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other