Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS OLYMPUS DUODENOSCOPE 180; ERCP
  • 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 OLYMPUS DUODENOSCOPE 180; ERCP Back to Search Results
Health Effect - Clinical Code No Information (3190)
Date of Event 07/15/2016
Type of Reportable Event Malfunction
Event or Problem Description
Through our routine microbiological surveillance cultures of duodenoscopes, we have identified an olympus duodenoscope (serial # (b)(4)) that has cultured (b)(4) for (b)(4) on 2 occasions despite several rounds of high level disinfection and sterilization.Once after our routine repeat high level disinfection process (2x hld) and then through the (b)(6) department of public health that the (b)(4) isolates only differed by three bands and are probably related.This despite 2 cycles of hld and one subsequent cycle of eo replacement of the elevator mechanism with the new parts per the fda recall.This duodenoscope was (b)(4) the last time it was cultured in december of 2015 (about 50 uses ago).From the information we have so far, we have not identified any adverse patient outcomes in patients who had this scope used on them between (b)(6) 2015 to present.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OLYMPUS DUODENOSCOPE 180
Common Device Name
ERCP
Manufacturer (Section D)
OLYMPUS
MDR Report Key5843105
Report NumberMW5063811
Device Sequence Number13012285
Product Code NWB
Initial Reporter StateMN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/01/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-