MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The causes of the reported events are unknown.Olympus will continue to investigate these reported events with the user facility and will update these reports accordingly.As part of our investigation into this report an olympus endoscopy support specialist (ess) has been dispatched to the user facility to observe the facility¿s reprocessing practices and to provide reprocessing training if necessary.

Event Description

Olympus was informed of (b)(6) patients that reportedly developed uti after having undergone a cystoscopy procedure.The user facility reported that all (b)(6) patients were examined with one cystoscope.The current conditions of the patients are unknown.This is 14 of 15 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the endoscopy support specialist (ess) findings and to update the following sections.The olympus ess visited the user facility on (b)(6) 2017 and observed the following reprocessing deviations: the reprocessing containers are not being cleaned after each use.The water tube was not replaced after each procedure and is being used throughout the day.The user facility does not have a suction machine in the reprocessing room and utilizes a syringe to aspirate the scope channels.After reprocessing, the scopes are laid down instead of being hung in a cabinet as stated in the reprocessing manual.After observing the user facility¿s reprocessing practice, a reprocessing training was provided and the deviations have been addressed and corrected with the user facility staff.In addition, the scope was cultured at the user facility and the scope culture tested negative for growth.Based on the ess findings, the cause of the reported event is likely attributed to insufficient maintenance of the device.The reprocessing manual states, ¿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.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.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.Hang the endoscope in the storage cabinet with the distal end hanging freely.Make sure that the insertion tube hangs vertically and as straight as possible.The storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Do not store in humidity, or exposed to x-rays and/or ultraviolet-rays.Doing so could damage the endoscope or present an infection control risk.¿.

Manufacturer Narrative

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

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• 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 ; 408935-512
• MDR Report Key: 6214869
• MDR Text Key: 63608165
• Report Number: 2951238-2016-01002
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Device Catalogue Number: CYF-V2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other