BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-EDGE MAYO SCS 6-3/4 STR

    MDR report key: 8103289 · Received November 26, 2018

    Report

    Report Number
    2523190-2018-00145
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    August 16, 2018
    Report Date
    November 2, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LRW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 27NOV2018: AN INTEGRA SITE MEETING WITH THE CUSTOMER IDENTIFIED THAT THERE WAS NO BIOBURDEN AS INITIALLY REPORTED, HOWEVER, THE ISSUE WAS RUST AND CORROSION. THE JARIT INSTRUMENTS WERE MANUALLY WASHED, PUT THROUGH AN ULTRASONIC BATH, AND THEN PLACED IN AN AUTOWASH WITH STERIS PROLYSTICA PH NEUTRAL DETERGENT. THE INSTRUMENTS CAME OUT WITH RUST STAINS. THE INSTRUMENTS WERE REWASHED, AND THE RUST DISSOLVED. THE INSTRUMENTS WERE THEN RAN THEM THROUGH THE AUTOCLAVE PROCESS, AND THE INSTRUMENTS CAME OUT WITH RUST STAINS. THE CLIENT HAS A KNOWN WATER PROBLEM. THE FINAL RINSE IN THE WASHING PROCESS IS WITH REVERSE OSMOSIS (R.O.) WATER. THE R.O. WATER SYSTEM WAS OFFLINE WHEN THE INCIDENT HAPPENED. THE SYSTEM WAS CLEANED BUT WELL WATER IN THE AREA IS HARD WITH HIGH IRON CONTENT. THIS COULD BE A ROOT CAUSE. HOWEVER, THE RUST STAINS ONLY HAPPEN WITH JARIT INSTRUMENTS AND NOT WITH INSTRUMENTS. THE CLIENT QUESTIONED THE FOLLOWING: IF THE SURFACE TEXTURE OF THE JARIT INSTRUMENTS, MATTE, MAKES IT EASY FOR RUST ORIGINATING IN THE HOSPITAL WATER SYSTEM TO ADHERE? IF THE RUST IS FROM IMPURITIES LEACHING OUT OF THE DEVICES. JARIT INSTRUMENT SUPPLIERS MAY BE USING RECYCLED METAL WITH A HIGHER CONTENT OF IMPURITIES. THESE DEVICE SUPPLIERS, EVEN IF SMALL COMPANIES, NEED TO BE AUDITED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. THE FINGER RING COATING WAS WORN/FADE WITH BROWN/BLACK CORROSION STAINS VISIBLE ON THE BLADE INTERIOR. CORROSION AND PITTING WAS NOTED BETWEEN THE BLADE AND INSERTS, AND NO PREVENTIVE MAINTENANCE MARKINGS WAS PRESENT. ADDITIONALLY, NO BIOBURDEN WAS DETECTED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBERS: 2523190-2018-00146, 2523190-2018-00147, 2523190-2018-00148, 2523190-2018-00149, 2523190-2018-00150, 2523190-2018-00151, 2523190-2018-00152, 2523190-2018-00153, 2523190-2018-00162, 2523190-2018-00154, 2523190-2018-00155, 2523190-2018-00156, 2523190-2018-00157, 2523190-2018-00163, 2523190-2018-00158, 2523190-2018-00159, 2523190-2018-00160, 2523190-2018-00161, 2523190-2018-00164, 2523190-2018-00165, 2523190-2018-00166, 2523190-2018-00167.

    Description of Event or Problem · 1

    THIS IS 1 OF 23 REPORTS. IT WAS REPORTED BY A CUSTOMER THAT A 101220 CARB-EDGE MAYO SCISSOR FAILED QUALITY CONTROL WITH A SUSPECTED BIOBURDEN, CAUSING AN OPERATING ROOM DELAY ON (B)(6) 2018, FOR AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 06NOV2018, STATING THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, IT WAS TESTED FOR PROTEINS AND REMOVED FROM THE FIELD. THE SURGICAL CASE WAS BROKEN DOWN. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. NO REPORTS OF PATIENT INJURY OR DEATH ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942734 CARB-EDGE MAYO SCS 6-3/4 STR N/A LRW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1