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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE Back to Search Results
Model Number PCF-H190L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus for evaluation. A review of the instrument¿s history was performed and found that the device had not been returned for service/ repair since the date of purchase on (b)(6) 2015. The cause of the reported event cannot be determined at this time. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly.
 
Event Description
Olympus was informed that two patients developed a carbapenem-resistant enterobacteriaceae (cre) infection after undergoing unspecified procedures using the colonovideoscope in (b)(6) 2018 and (b)(6) 2018. The patient¿s course of treatment is unknown. In addition, the user facility reported that the colonovideoscope was sent to a third party for culturing and tested negative for growth. This is report 2 of 2.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information received. Olympus received additional information that states patient 1 was underwent both upper/lower endoscopy on october 12, 2018 over the course of a couple of days. The patient¿s urinalysis was positive for the new delhi strain of cre at a week post procedure. Patient 2 had an upper endoscopy performed on december 13, 2018 and tested positive for cre. Both patients were treated with antibiotics. According to the facility¿s director of perioperative services the state is linking these cases to a rehabilitation/nursing facility within 20 miles of this hospital. The state is also requesting that the facility send these three scopes out to be cultured. Additionally, the user facility reported that their scopes are pre-cleaned using intercept enzymatic. The scope is leak tested prior to manual cleaning, the endoscope channel is being brushed during manual cleaning, the facility utilizes single use brushes. The scopes are reprocessed using the medivators dsd and medivators dsd-201 with rapicide (sn# 201202006 and 201202007). Then stored in a hanging cabinet. The facility's last in-service with an olympus ess was performed back in july 2018. The facility reports that there has been no change to the reprocessing staff since the last in-service and all staff is trained to properly reprocess a scopes.
 
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Brand NameEVIS EXERA LLL COLONOVIDEOSCOPE
Type of DeviceCOLONOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8143728
MDR Text Key129754438
Report Number2951238-2018-00748
Device Sequence Number1
Product Code FDF
UDI-Device Identifier04953170305191
UDI-Public04953170305191
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCF-H190L
Device Catalogue NumberPCF-H190L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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