BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 8918077 · Received August 21, 2019

    Report

    Report Number
    2084725-2019-00926
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH HISTORY SHOWS ALL THE REQUIRED PROCESS CHECKS ARE COMPLETE AND ACCEPTABLE. THERE WERE NO ANOMALIES IDENTIFIED. THIS LOT MET SPECIFICATIONS AT THE TIME OF RELEASE. AN ASP REPRESENTATIVE PROVIDED RE-TRAINING TO THE STAFF AT THE FACILITY ON PROPER HANDLING AND USE OF DISOPA. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 0

    H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING BY LOT NUMBER, FUNCTIONAL ANALYSIS, SUPPLIER EVALUATION AND RETAINS ANALYSIS. ¿ TREND ANALYSIS BY LOT NUMBER WAS REVIEWED FROM FOR THE SIX MONTHS PRIOR TO OPEN DATE AND REVEALED TRENDING WAS NOT EXCEEDED. ¿ THE SUPPLIER CONFIRMED ALL THE WEIGHING, MIXING, FILLING AND IN-PROCESS RECORDS FOR THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE AND CONFIRMED THAT NO PROCESS OF MANUFACTURE AND PRESCRIPTIONS HAVE CHANGED AFTER THE LAST CHANGE. THE ASSIGNABLE CAUSE OF THE REPORTED ISSUE CANNOT BE VERIFIED. THE CUSTOMER RETURNED DISOPA SOLUTION FOR EVALUATION HOWEVER IT IS UNKNOWN IF THE LOT RETURNED WAS USED WITH THE REPORTED EVENT SINCE THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. ASP COMPLAINT REF #: PC-(B)(4).

    Additional Manufacturer Narrative · 1

    "A CASE OF ANAPHYLAXIS WITH POOR SKIN SYMPTOMS IN LARYNGEAL ENDOSCOPY IN WHICH PHTHARAL SKIN TEST WAS FOUND USEFUL FOR DIAGNOSIS". DEPARTMENT OF ALLERGY AND CLINICAL IMMUNOLOGY, CHIBA UNIVERSITY HOSPITAL DEPARTMENT OF HEAD AND NECK SURGERY / OTOLARYNGOLOGY, NATIONAL HOSPITAL ORGANIZATION CHIBA MEDICAL CENTER DEPARTMENT OF OTORHINOLARYNGOLOGY / HEAD AND NECK SURGERY, CHIBA UNIVERSITY HOSPITAL DEPARTMENT OF DERMATOLOGY, NATIONAL HOSPITAL ORGANIZATION CHIBA MEDICAL CENTER AUTHORS: TOMOHIRO TAMACHI, KAITO NAKAMURA, RIE NIIMI, NAOKI KUNII, MICHIYO OKUBO, AIKO SAKU, ARIFUMI IWATA, YUKO MAEZAWA, KOICHI HIROSE, HIROSHI NAKAJIMA INITIAL REPORTER PHONE #: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. DEVICE EVALUATED BY MANUFACTURER. THE CUSTOMER RETURNED ONE BOTTLE OF DISOPA SOLUTION LOT F000035851 FOR FUNCTIONAL TESTING. ALL WEIGHING, MIXING, FILLING AND IN-PROCESS RECORDS FOR THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. IT IS UNKNOWN WHETHER OR NOT THIS RETURNED LOT WAS USED WITH THE INSTRUMENT THAT WAS USED ON THE PATIENT WITH ANAPHYLAXIS. RETAINS TESTING WAS PERFORMED AND THE SUPPLIER CONFIRMED ALL TESTING MET PRODUCT SPECIFICATIONS. ASP COMPLAINT REF #: (B)(4).

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED A CASE STUDY TITLED, "A CASE OF ANAPHYLAXIS WITH POOR SKIN SYMPTOMS IN LARYNGEAL ENDOSCOPY IN WHICH PHTHARAL SKIN TEST WAS FOUND USEFUL FOR DIAGNOSIS" AND WAS PRESENTED AT THE 1ST KANTO REGIONAL MEETING OF JAPANESE SOCIETY OF ALLERGOLOGY HELD ON 03/16/19. THE STUDY REPORTED A (B)(6)-YEAR-OLD, MALE PATIENT WHO EXPERIENCED ANAPHYLAXIS AFTER AN ENDOSCOPIC PROCEDURE, AND THE ENDOSCOPE MAY HAVE BEEN CLEANED AND DISINFECTED WITH DISOPA SOLUTION. THE PATIENT HAD A HISTORY OF TREATMENT FOR OROPHARYNGEAL CANCER TWO YEARS PRIOR TO A FOLLOW-UP LARYNGEAL ENDOSCOPY. THE DATE OF THIS FOLLOW-UP PROCEDURE IS NOT KNOWN, BUT IT WAS NOTED IN THE CASE PRESENTATION THAT 30 MINUTES AFTER THE PROCEDURE THE PATIENT DEVELOPED LACRIMATION AND RHINORRHEA. THEN 120 MINUTES LATER, THE PATIENT WAS RE-EXAMINED AND DEVELOPED STRONG LARYNGEAL EDEMA WHICH RESULTED IN AN EMERGENCY TRACHEOTOMY. SKIN SYMPTOMS WERE ONLY MILD ERYTHEMA AND PRURITUS ON THE BACK OF THE HANDS. IT WAS ALSO REPORTED IN THE CASE PRESENTATION, THE PATIENT HAD AN ALLERGY SKIN TEST, AND THE SKIN PRICK TEST FOR ¿ENDOSCOPIC DISINFECTANTS PHTHARAL 0.55%¿ (DISOPA) WAS POSITIVE WITH A 10 X 10 MM WHEAL. THE PATIENT HAD NO SYMPTOMS RELATED TO OTHER SUSPECTED REAGENTS USED DURING ENDOSCOPY. ADVANCED STERILIZATION PRODUCTS (ASP) REQUESTED ADDITIONAL CLINICAL INFORMATION REGARDING THIS PATIENT, BUT THE AUTHORS OF THIS CASE PRESENTATION ARE NO LONGER AT THE HOSPITAL. THE DATE OF THE FOLLOW-UP PROCEDURE IS NOT KNOWN. FURTHERMORE, IT IS NOT KNOWN HOW MANY PROCEDURES THE PATIENT HAD OVER THE YEARS WITH INSTRUMENTS REPROCESSED WITH DISOPA SOLUTION, POTENTIALLY CAUSING SENSITIZATION. REGARDING THE HOSPITAL¿S NORMAL REPROCESSING PRACTICE, IT WAS REPORTED THAT AFTER PRE-CLEANING OF THE ENDOSCOPE, DISOPA SOLUTION IS USED WITH AN AUTOMATIC ENDOSCOPE REPROCESSOR (AER), A NON-ASP DEVICE. THE AER STANDARD CYCLE IS USED, WHICH INCLUDES DISINFECTION FOR 5 MINUTES, RINSING FOR 2 MINUTES, AND DRYING FOR 1 MINUTE. IN ADDITION, THE CUSTOMER STATED THE MANUFACTURER OF THE AER RECOMMENDS USE OF DISOPA SOLUTION. IT IS UNCLEAR IF THE ENDOSCOPE USED IN THE FOLLOW-UP PROCEDURE WAS REPROCESSED IN THE AER WITH DISOPA SOLUTION OR MANUALLY REPROCESSED, SINCE THE AUTHORS OF THIS CASE PRESENTATION ARE NO LONGER AT THIS HOSPITAL TO DISCUSS. BASED ON LIMITED INFORMATION RECEIVED, AND OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY FOR THE REPORT OF ANAPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707543 DISOPA SOLUTION BIOCIDES SOLUTIONS MED ADVANCED STERILIZATION PRODUCTS F00035851

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| O| R