BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX ED-3490TK; VIDEO DUEDENOSCOPE

    MDR report key: 6753465 · Received July 31, 2017

    Report

    Report Number
    6753465
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 26, 2017
    Manufacturer
    PENTAX OF AMERICA, INC.,
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    AN INVESTIGATION BEGAN TO IDENTIFY IF THE PATIENT HAD HAD ANY INVASIVE PROCEDURES; IT WAS QUICKLY IDENTIFIED THAT THE ERCP WAS THE ONLY INVASIVE PROCEDURE. THE DUODENOSCOPE WAS IDENTIFIED AND SEQUESTERED THE NEXT DAY. TIMELINE RELATED TO EXPOSED PATIENTS INCLUDES: INITIAL EXPOSURE, THE #1 PATIENT HAD BEEN EXPOSED VIA THE DUODENOSCOPE. A FEW DAYS LATER, THE #2 PATIENT HAD BEEN EXPOSED VIA THE DUODENOSCOPE. THE NEXT DAY, THE #3 PATIENT HAD BEEN EXPOSED VIA THE DUODENOSCOPE. EACH OF THE ABOVE THREE PATIENTS TESTED NEGATIVE FOR MCR-1. THE NEXT DAY, AN EXPOSED #4 PATIENT VIA DUODENOSCOPE LATER TESTED POSITIVE A FEW WEEKS AFTER EXPOSURE FOR THE MCR-1 BACTERIA. THIS WAS IDENTIFIED AS CASE #2. SEVERAL DAYS LATER, A #5 PATIENT HAD BEEN EXPOSED VIA THE DUODENOSCOPE. #5 PATIENT TESTED NEGATIVE FOR THE BACTERIA. A FEW DAYS LATER, TESTING DONE ON A WOUND/DRAIN CULTURE FROM PATIENT EXPOSED #4/CASE #2 GREW CTX-R KLEBSIELLA PNEUMONIA. A FEW DAYS LATER, THE MICROBIOLOGY LAB REPORTED COLISTIN MIC = 4 UG/ML (PERFORMED BY BROTH DILUTION). THE ISOLATE WAS SENT TO THE CDC. A FEW WEEKS LATER, THE OFFSITE AGENCY CONFIRMED MCR-1 IN CASE #2. ADDITIONAL TESTING WAS REQUESTED. LATER THAT DAY, THE DUODENOSCOPE CULTURE RETURNED NEGATIVE. WHOLE GENOME SEQUENCING (WGS) ANALYSIS WAS ON GOING AT THE OFFSITE AGENCY INCLUDING SEQUENTIAL CLINICAL AND SURVEILLANCE ISOLATES FROM CASE 1 AND 2. ADDITIONAL INFORMATION WAS BEING RECEIVED FROM THE OFFSITE AGENCY REGARDING THE GENOME SEQUENCING DURING THE NEXT MONTH. THE INFORMATION REGARDING THE STRAINS FROM CASE 1 AND CASE 2 RECEIVED FROM THE AGENCY WAS REVIEWED BY HOSPITAL LEADERS FROM INFECTIOUS DISEASE, INFECTION CONTROL, CLINICAL ENDOSCOPY, AND QUALITY AND SAFETY A FEW WEEKS LATER. THE SIMILARITY OF STRAINS WAS SUFFICIENTLY LARGE THAT THE GROUP CONCLUDED THAT THERE WAS PROBABLE TRANSMISSION. DEFINITIVE EVIDENCE IS PENDING THE RESULTS OF ADDITIONAL WHOLE GENOME SEQUENCING (WGS) ANALYSIS FROM THE OFFSITE AGENCY WHICH SHOULD RETURN AFTER SEVERAL WEEKS. A FEW WEEKS LATER, AFTER COMMUNICATION WITH FEDERAL AGENCIES AND PENTAX, IT WAS DECIDED THAT THE SUSPECT SCOPE WOULD BE SENT TO THE OFFSITE AGENCY FOR EXAMINATION. MANUFACTURER RESPONSE FOR PENTAX VIDEO DUODENOSCOPE, PENTAX D2 MODEL ED 3490TK (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535395 PENTAX ED-3490TK; VIDEO DUEDENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT PENTAX OF AMERICA, INC., ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other LONG-TERM ANTIBIOTICS| NO OTHER DEVICES WERE SPECIFICALLY BEING USED ON T