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Model Number CYF-V2
Device Problems Endoscope (802); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 01/03/2017
Event Type  Injury  
Manufacturer Narrative

The scope was returned to olympus for evaluation; however, the device evaluation has not yet begun. The scope will be sent to an independent laboratory for culture testing and ethylene oxide (eto) sterilization. As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility on (b)(6) 2017 to observe the facilities reprocessing practice and to provide a reprocessing training. The ess found reprocessing deviations with leak testing, manual cleaning, and high level disinfection of the scope and the scope connectors. The ess educated the user facility on the following: leak testing should be completed after each use. Proper dilution of flexclean according to the mixing instruction must be followed. Proper brushing of scope has to be performed and worn brushes have to be replaced. Proper disinfection and cleaning of reusable brushes has to be performed. Properly testing the aldahol solution with test strips and logging the test results. In addition to educating the user facility staff of proper reprocessing practices, the ess provided the staff a cleaning guide wall poster information. Based on several reprocessing deviations that the ess found during the on-site visit, the cause of the reported patient infections is likely attributed to insufficient reprocessing of the scope. The reprocessing manual for use provides several warning and caution statements in an effort to prevent patient infection and cross contamination. ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization. Reprocess not only the external surface of the endoscope but also all channels. All channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure. If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible. Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms and organic material that could reduce the efficacy of disinfection or sterilization. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. ¿.

Event Description

Olympus was informed that nine patients became infected with pseudomonous aeruginosa after undergoing a cystoscopy procedure. One of the nine patients was sent to icu for sepsis. All patients were given antibiotics and have since recovered. The user facility further reported that the scope is reprocessed using flexclean 895 solution and aldahol. The minimum effective concentration is being checked weekly. The scope is manually cleaned using a reusable brush (model unknown). Pre-cleaning is performed immediately after each procedure. The scope is rinsed/wiped off with a mix of water and flexclean 895 then the reusable brush is used to scrub out the internal channels of the scope. The scope is then soaked in a mix of flexclean 895 for 2 minutes before transferring the scope to the disinfectant solution. The scope is leak tested prior to manual cleaning using an olympus wa23080a leak tester. The scope is stored in a non-olympus aztec endocaddy holder. This is 6 of 9 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the independent laboratory results. The scope was sent to an independent laboratory for culture testing. The scope tested negative for growth. The scope was then ethylene oxide (eto) sterilized and returned to olympus for a physical device evaluation. A visual inspection was performed on the scope and noted brownish stains on the distal end cover and objective lens glue. In addition, a boroscope was used inspect the biopsy channel and found tear marks near the distal end and bending section side of the scope. There were no signs for foreign materials found on the bending section cover, bending section cover glue and insertion tube. The scope passed leak testing. The scope was serviced and returned to the user facility. Based on the tear marks found on the biopsy channel and brownish stain found on the distal end cover, user handling and improper maintenance could not be ruled out as contributory factors to the reported event.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
MDR Report Key6513959
MDR Text Key73448579
Report Number2951238-2017-00282
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device MODEL NumberCYF-V2
Device Catalogue NumberCYF-V2
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
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

Date Received: 04/22/2017 Patient Sequence Number: 1