BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRW PRECISION ARC SYSTEM STERLIZATION CASE

    MDR report key: 4585005 · Received March 6, 2015

    Report

    Report Number
    1222895-2015-00008
    Event Type
    Injury
    Date Received
    March 6, 2015
    Report Date
    December 11, 2014
    Manufacturer
    INTEGRA BURLINGTON MA, INC
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CRW PRECISION STERILIZATION CASE WAS TEARING WRAPS/DRAPES. THERE WAS NO PATIENT CONTACT, NO PATIENT INJURY, AND NO REVISION OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2015, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER: THE PROBLEMS WERE BEING DISCOVERED ONCE THE SET WAS IN THE OPERATING ROOM (OR). IT WAS REPORTED THAT IT WAS ALMOST CONSISTENT THAT EVERY TIME THE CUSTOMER WOULD STERILIZE THE SETS, THEY WOULD HAVE HOLES IN THE WRAPS BEFORE GETTING TO THE PATIENT. THERE WERE GRAY PLASTIC CORNERS ON THE INSTRUMENT CASE THAT WERE SUPPOSED TO BE PROTECTING FROM HOLES, BUT THEY WERE ACTUALLY CAUSING THE HOLES. THERE WERE 4 OF THESE ON EACH CORNER CAUSING 16 DIFFERENT PLACES THAT THEY COULD CAUSE A HOLE. DATE OF THE INCIDENT WERE REPORTED AS "MULTIPLE DATES". PATIENT AGE, GENDER, TYPE OF SURGERY WERE UNKNOWN. THERE WAS NO PATIENT HARM OR INJURY. HOWEVER, THE PATIENT WAS ALREADY ANESTHETIZED WHEN THE PROBLEM OCCURED. SURGERY DELAY WAS REPORTED AS "MULTIPLE TIMES. USUALLY AT LEAST AN HOUR DELAY." THE SET WAS RESTERILIZED AS SOON AS POSSIBLE AND THEN THE PRODUCT WAS USED ON THE PATIENT AFTER RESTERILIZATION OF THE PRODUCT. PATIENT ADVERSE CONSEQUENCE AS A RESULT OF THE SURGICAL DELAY WAS UNKNOWN. IT WAS REPORTED THAT ULTIMATELY THE CUSTOMER CUT THE GRAY CORNERS OFF THE TRAY. REQUEST FOR ADDITIONAL INFORMATION/CLARIFICATION WAS SENT, SPECIFICALLY SINCE IT WAS REPORTED THAT THE PROBLEM HAD OCCURRED MULTIPLE TIMES. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158457 CRW PRECISION ARC SYSTEM STERLIZATION CASE STEREOTAXY HAW INTEGRA BURLINGTON MA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other