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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Patient Involvement (2645)
Event Date 10/06/2020
Event Type  Malfunction  
Manufacturer Narrative

The device will not be returned to the service center for evaluation. As part of our investigation, while onsite the ess provided the customer with an in-service that included: pre-cleaning, modified manual cleaning, and storage in accordance with the manufacturer¿s recommendations. In addition, the customer was provided the endoscope cleaning wall charts.

 
Event Description

The service center was informed that during an onsite in-service with an endoscopy support specialist (ess) the customer explained the facility¿s current reprocessing methods. The ess observed that the customer had tubes on the wall that held disinfectant and that only the insertion portion of the scope was inserted into the tube. The ess also observed sterile water in a tube that was used to rinse the scope. The ess noted that the eyepiece and control section was not submerged. The customer reported that the eyepiece was not submerged due to concerns that the disinfectant would irritate the doctor¿s eyes. Also, concerned about disinfectant vapor without proper ventilation. There was no patient infection, patient involvement or device positive culture reported.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key10778780
MDR Text Key224632801
Report Number8010047-2020-08463
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/01/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2012
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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