• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Date 08/11/2020
Event Type  Injury  
Event Description
The customer reported to olympus the evis exera ii duodenovideoscope was a scope of potential infection after being notified by the maine center for disease control (cdc) that they were dealing with a carbapenem-resistant enterobacterial (cre) organism. The scope of concern was cultured by the customer on (b)(6) 2020, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021. On (b)(6) 2021 the scope was tested after a known cre case. The scope tested negative after each culture on (b)(6) 2020, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021. The epidemiologist was made aware of a cluster of patients that were infected over 1 year ago with carbapenem-resistant enterobacteriaceae (highly resistant cp-cre organism). A "few patients" tested positive; however, reprocessing department was never informed. The reprocessing department was instructed to pull the device out of service on (b)(6) 2021. The device was cultured on (b)(6) 2021. The culture was done after the device had been disinfected numerous times as the patient infection occurred in (b)(6) 2020. The device culture was negative. The customer further reported that they had three patients who had been examined by this particular scope and were genetically identical e. Cloacae. This complaint is for patient 2, a (b)(6) year old female weighing (b)(6) kilograms with a medical history of pneumonia, hypertension, hypothyroidism, paroxysmal atrial fibrillation, and peptic ulcer disease. The patient was scoped with the subject device for biliary obstruction and cholangioca (b)(6) 2020 and (b)(6) 2020. The patient was later diagnosed with sepsis after her blood was cultured and tested positive for kpc-e. Cloacae on (b)(6) 2021. The patient received iv antibiotics for sepsis and her current status is reported as living. Patient identifier (b)(6) is for patient 1 of 3. Patient identifier (b)(6) is for patient 3 of 3. This complaint is for patient identifier (b)(6) for patient 2 of 3.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVIS EXERA II DUODENOVIDEOSCOPE
Type of DeviceDUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key12557860
MDR Text Key274219843
Report Number2951238-2021-00421
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/24/2021,09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/24/2021
Event Location Hospital
Date Report to Manufacturer09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
-
-