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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS OLYMPUS 160/180 SERIES ENDOSCOPE ERCP SCOPE 1160

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OLYMPUS OLYMPUS 160/180 SERIES ENDOSCOPE ERCP SCOPE 1160 Back to Search Results
Lot Number 2001160
Device Problem Device Contamination With Biological Material (2908)
Patient Problem Bacterial Infection (1735)
Event Date 02/27/2013
Event Type  Malfunction  
Event Description

Over a 2 year period, there was an increase in the number of kp resistant microbiology (kpc) reported results. During investigation, it was determined that a small percentage of involved patients had undergone endoscopic procedures. Endoscopes were cultured by microbiology department. One endoscope tested positive for kpc following disinfection. The endoscope was removed from use. (b)(6) was consulted. A review of endoscope cleaning, disinfection and related processes was documented by (b)(6). Staff were interviewed, reprocessing documents reviewed, audits completed. The subject endoscope was tested by third party laboratory, (b)(4). Third party laboratory culture results were negative for kpc. Investigation and analysis of kpc is ongoing and sources of kpc remains undetermined at this time. Official olympus report received, root cause unknown. Dates of use: (b)(6) 2011 - (b)(6) 2012.

 
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Brand NameOLYMPUS 160/180 SERIES ENDOSCOPE
Type of DeviceERCP SCOPE 1160
Manufacturer (Section D)
OLYMPUS
2400 ringwood ave.
san jose CA 95131
MDR Report Key2999629
MDR Text Key3388801
Report NumberMW5029305
Device Sequence Number1
Product Code FDS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number2001160
OTHER Device ID NumberTJF-Q180V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2013
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/04/2013 Patient Sequence Number: 1
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