BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM REUSABLE ANGIOSCOPE

    MDR report key: 91103 · Received May 10, 1997

    Report

    Report Number
    2027111-1997-00009
    Event Type
    Malfunction
    Date Received
    May 10, 1997
    Date of Event
    April 10, 1997
    Report Date
    April 11, 1997
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    LYK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO DOCUMENT DEVICE EVALUATION H7 REFERS TO VOLUNTARY FIELD CORRECTION ACTIVITIES AS DEFINED IN THE ATTACHED EVALUATION REPORT. -MDR #2027111-1997-00009 WAS FILED WITH FDA DOCUMENTING EVENT. -MRR #7762 WAS STARTED TO EVALUATE 5 SCOPES FROM THE SAME LOT BUILT IN 1995. EACH OF THESE SCOPES WAS WIPED WITH A KIM WIPE AND STERILE WATER TO SEE IF STRIPES COULD BE REMOVED WITH THIS METHOD. IN THIS EVAL, INK DEMONSTRATED ACCEPTABLE INTEGRITY AND RESISTANCE TO EXPECTED ABRASION. -STERILIZATION QUALIFICATIONS FOR THIS MODEL SCOPE WERE REVIEWED. UPON DOING SO, CO FOUND THAT SCOPE, ALONG WITH CENTIMETER MARKER BANDS, HAD BEEN DESIGN VALIDATED FOR USE WITH BOTH STERIS AND ETO STERILZATION METHODS. -CONTINUING IN CO'S EVAL, CO REVIEWED CER/MDR RECORDS TO SEE IF THERE HAD BEEN ANY OTHER SIMILAR INCIDENTS FOR THIS PRODUCT. THIS REVIEW PROCESS SHOWED THAT NO OTHER INCIDENTS OF THIS NATURE HAD BEEN FILED. -MRR #799 WAS CREATED TO PULL REMAINING 2.3MM RESUABLE ANGIOSCOPES OUT OF FINISHED GOODS PENDING FURTHER INVESTIGATION. -FURTHER EVAL OF SCOPES PULLED ON MRR #7762 WAS CONDUCTED. ONE SCOPE WAS SENT THROUGH(1) STERIS CYCLE, AND ONE SCOPE WAS SENT THROUGH (1) ETO CYCLE. UPON RETURN, THEY WERE AGAIN WIPED WITH A KIM WIPE AND STERILE WATER. THIS TIME, INK WAS ABLE TO BE WIPED OFF OF BOTH SCOPES WITH MODERATE ABRASION FROM OPERATOR. THUS, CUSTOMER'S CLAIM WAS CONFIRMED. ALTHOUGH REVIEW OF CER/MDR RECORDS SHOWED NO OTHER INCIDENTS, BASED ON ABOVE FINDINGS, THIS INCIDENT COULD HAPPEN AGAIN. FLAKING OFF OF INK SEEMS TO BE A FUNCTION OF AGING PROCESS IN CONJUNCTION WITH A STERILIZATION CYCLE IN REGARDS TO 2.3MM RESUSABLE SCOPE'S PARTICULAR COMBINATION OF WHITE INK AND HYTREL TUBING MATERIAL. TYPE OF STERILZATION CYCLE DOES NOT MATTER. IT IS ENGINEERING'S RECOMMENDATION TO REMOVE STRIPES FROM ALL CURRENT PRODUCT OF THIS MODEL THAT IS IN QUARANTINE. ALL FUTURE PRODUCT OF THIS MODEL SHOULD NOT BE PRODUCED WITH CENTIMETER MARKS, AND ANY CUSTOMER HTA HAS RECEIVED A 2.3MM RESULABE ANGIOSCOPE WILL BE ISSUED INSTRUCTIONS TO RETURN SCOPES TO APPLIED MEDICAL FOR CORRECTION. CENTIMETER MAKRKS CAN BE REMOVED, WITHOUT DAMAGE TO HYTREL MATERIAL (SEE ATTACHED CHEMCIAL RESISTANCE INF) BY APPLYING ISOPROPYL ALCOHOL AND MILD ABRASION TO MARKS. SINCE OTHER ANGIOSCOPES DO NOT USE SAME TUBING MATERIAL AND INK COMBINATION, THEY DO NOT HAVE SAME PROBLEM, AND THUS DO NOT REQUIRE FURTHER ACTION. MRR #7762 WILL BE CLOSED WITH EVAL OF FINISHED SCOPES COMPLETED. MRR #7791 WILL BE CLOSED AFTER ADDING A STEP TO REMOVE EXISTING STRIPES FROM SCOPES (SEE ATTACHED INSTRUCTION SHEET) AND RETURN THEM TO FINISHED GOODS.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT DURING AN INSITU FEMORAL TIBIAL BYPASS, DR NOTICED PARTICULATE IN THE FIELD OF VIEW. THE SCOPE WAS REMOVED AND IT WAS DETERMINED THAT PART OF THE PAINTED "CM" MARKS ON THE SCOPE SHAFT WERE MISSING. THE DOCTOR FLUSHED THE VESSEL TO REMOVE ANY POTENTIAL PARTICULATE. THE PT WAS REPORTED TO BE DOING FINE. AFTER THE PROCEDURE, THE DOCTOR CHOSE TO REMOVE THE REMAINING "CM" MARKS AND WILL CONTINUE TO USE THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3MM REUSABLE ANGIOSCOPE ANGIOSCOPE LYK APPLIED MEDICAL RESOURCES A5103 95E183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention