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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2R
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Date 09/16/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. As part of our investigation, on september 21, 2020, an endoscopic support specialist (ess) was dispatched to the user facility to follow up on the customer¿s concern. Also, the ess would observe the facility¿s reprocessing methods during this visit. The ess noted the following deviations during the reprocessing observation: scopes were not being leak tested nor fully submerged during manual cleaning and high level disinfection. In addition, more than the required chemicals for reprocessing were being used. The ess reported that the customer was advised on those issues and provided recommendations / education to complete reprocessing according to instructions. On september 22, 2020, the ess returned to the user facility and provided a complete reprocessing in ¿service which included demonstrating reprocessing steps according to the manufacturer¿s recommendations. The ess reported that the customer¿s questions related to the reprocessing workflow were addressed during this visit. The ess advised the customer leak testing must be performed and showed how using a third party leak testing device on site. The ess also provided the customer with the following additional recommendations: the use of a mu-1 / mb-155 to avoid fluid invasion in leaking scopes. Promoted the use of larger / adequately sized basins to perform manual cleaning with scopes fully submerged as well as high level disinfection with scope fully submerged. Advised against the use of chemicals over and above what is required as more chemicals in use can cause issues with residue and water quality. Advised against the use of wall hanging tubes for storage due to concerns they do not disinfect or allow the scope to air dry properly. The ess reported the customer was provided a copy of the reprocessing poster and confirmed the customer had ifu on hand for reference. The instruction manual states ¿after using this instrument, reprocess and store it according to the instructions given in chapter 5, ¿reprocessing: general policy¿ through chapter 8, ¿storage, transporting and disposal¿. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance. ¿.

 
Event Description

The service center was informed that a brown residue was noted on the scope¿s button on the left hand side. There was no patient involvement.

 
Manufacturer Narrative

This supplemental report is being submitted to provide additional information received. Please see the updates in sections. Upon further review, this is not a reportable malfunction. Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10673385
MDR Text Key223663228
Report Number8010047-2020-07632
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
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2R
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2020
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

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