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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-V2
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the service center for evaluation. A review of the instrument history revealed no record of service/repair for this device since the date of purchase on (b)(6) 2019. As part of our investigation, the ess informed the facility¿s staff of the importance of completing the rinsing properly to remove hld from the scope. The staff reported that the rinsing would be properly implemented. On (b)(6) 2020 the ess performed a follow up call to the facility to discuss that the improper handling likely caused the staining and to offer a reprocessing in-service. The facility agreed to participate in the in-service; however, no date was finalized. The ess has followed up with the facility staff via telephone and in writing but with no result. The cyf-v2 instruction manual states in the ¿reprocessing before the first use/reprocessing and storage after use¿ section that ¿ this instrument was not cleaned, disinfected, or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in chapter 5, ¿reprocessing: general policy¿ through chapter 7, ¿cleaning, disinfection, and sterilization procedures¿. 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 the user facility was improperly reprocessing two cysto-nephro videoscopes. During a telephone consult with an endoscopy support specialist (ess) the user facility¿s staff reported the high level disinfectant (hld) was staining the scopes. Also, that the scopes were not being adequately rinsed after being soaked in the hld. There was no patient involvement reported. This is 1 of 2 reports.
 
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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 Key10877668
MDR Text Key225647932
Report Number8010047-2020-09239
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-V2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2019
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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