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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS OLYMPUS ERCP SCOPE
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OLYMPUS OLYMPUS ERCP SCOPE Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); No Information (3190)
Event Date 02/13/2016
Event Type  Injury  
Event Description
Ercp scope was used on a patient with known cre colonization ((b)(6)).The facility followed our routine practice which consists of pre-cleaning and manual cleaning per mfr instruction, utilizing atp testing to validate cleaning effectiveness (rlu well below threshold for action/recleaning), and 2 rounds of high level disinfection in an aer using rapicide peracetic acid solution and meeting all cycle parameters.Ercp scope was used on 2 add'l patients who have not yet presented with any infectious complication.The ercp scope was used on the third patient who returned 18 days later with infectious complications ((b)(6)).Culture revealed that (b)(6) has the same organism, same sensitivity pattern and pfge type match as (b)(6).Gene sequencing of the carbapenemase genes is currently underway.
 
Event Description
Ercp scope was used on a patient with known cre colonization ((b)(6)).The facility followed our routine practice which consists of pre-cleaning and manual cleaning per mfr instruction, utilizing atp testing to validate cleaning effectiveness (rlu well below threshold for action/recleaning), and 2 rounds of high level disinfection in an aer using rapicide peracetic acid solution and meeting all cycle parameters.Ercp scope was used on 2 add'l patients who have not yet presented with any infectious complication.The ercp scope was used on the third patient who returned 18 days later with infectious complications ((b)(6)).Culture revealed that (b)(6) has the same organism, same sensitivity pattern and pfge type match as (b)(6).Gene sequencing of the carbapenemase genes is currently underway.
 
Event Description
Add'l info received from reporter on 05/16/2016 for mw5061659.Updated info: whole genome sequencing indicates that the pts' isolates are closely related.
 
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Brand Name
OLYMPUS ERCP SCOPE
Type of Device
OLYMPUS ERCP SCOPE
Manufacturer (Section D)
OLYMPUS
MDR Report Key5573464
MDR Text Key42585860
Report NumberMW5061659
Device Sequence Number0
Product Code FDT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/12/2016
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization;
Patient Age67 YR
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