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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE Back to Search Results
Model Number CF-H180AI
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/17/2017
Event Type  Injury  
Manufacturer Narrative

The subject scope has not been returned for evaluation. The user facility noted the scope would be sent to an independent laboratory for culture testing. To date, no additional information has been received. The user facility reported that the scope was sent in for repair after the december procedure and had a leak. The scope was repaired and returned at that time. As part of our investigation, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training. The ess observed following deviations: during leak testing procedure, angulating of the bending section and proper removal and disconnection from the mu-1 device. During manual cleaning, there is deviation in the order of brushing and how many times the steps are being performed with the scope out of the detergent solution. There was several occasions where the channel opening was brushed first, followed by the suction channel. In addition, there was inconsistent drying of the scope before placement in the aer. The user facility acknowledged the improvements needed in the reprocessing steps and will conduct competency checks on staff more often ess also conducted in-service which included leak testing, manual cleaning, disinfecting, sterilization and storage information contained in the reprocessing manual. The cause of the patient infection cannot be confirmed, however, if additional information becomes available or if the scope is returned at a later date, this report will be supplemented accordingly. As a preventive measure, the scope's reprocessing manual provides warning to mitigate the risk of patient infection which states: all disinfection methods (whether performed manually or by an automated endoscope reprocessor), and all sterilization methods (whether performed by ethylene oxide gas or steam) require thorough prior cleaning of the instrument being reprocessed. If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope. All channels of the endoscope, including the instrument channel and the auxiliary water channel, and all accessories used with the endoscope during the patient procedure, such as all valves and the auxiliary water tube (maj-855), must be cleaned and high-level disinfected or sterilized after each patient procedure, even if the channels or accessories were not used during the patient procedure. Insufficient cleaning and disinfection or sterilization of these components may pose an infection control risk to patients and/or operators.

 
Event Description

The manufacture was informed that after a colonoscopy procedure on (b)(6) 2018, the patient ¿s urine tested positive for carbapenem-resistant enterobacteriaceae (cre) sometime in (b)(6) 2019.

 
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Brand NameEVIS EXERA II COLONOVIDEOSCOPE
Type of DeviceCOLONOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose , CA 95131
4089355124
MDR Report Key8683917
Report Number2951238-2019-00926
Device Sequence Number1
Product CodeFDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCF-H180AI
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/10/2019 Patient Sequence Number: 1
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