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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 Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Patient Involvement (2645)
Event Date 05/26/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not returned for evaluation. The endoscopy support specialists(ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide reprocessing training. To date, the ess visit has not been finalized. To date there was no patient harm or infection was reported. If additional information becomes available this report will be supplemented accordingly.

 
Event Description

It was reported that the user site would not sterilize the scope for two days. According to the reporter when the user was performing bedside manual cleaning after the scope was used in a procedure, the scope is kept moist with an enzymatic spray. Sterilization is done off site and may not be completed until up to 2 days following the manual cleaning. According to the reporter, the user was unaware of any harm caused by their process. No patient impact or injury was reported.

 
Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), the device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria. No abnormalities were found. It was reported that the user site would not sterilize the scope for two days. According to the reporter when the user was performing bedside and manual cleaning after the scope was used on a procedure, the scope is kept moist with an enzymatic spray. Based on the investigation results, per the reported description in which the endoscope has not been sterilized for two days after precleaning, manual cleaning and the endoscope was moistened with enzyme spray, it was highly likely that the subsequent sterilization process will be adversely affected. The process the user conducted should not be performed. Even though the correct procedure is to sterilize the endoscope immediately after performing manual cleaning, if immediate sterilization is not possible, after cleaning it is recommended to leave the instrument completely dry, not moistened because it is highly possible that subsequent sterilization can be effectively processed normally by drying the equipment. Olympus will continue to monitor complaints for this device.

 
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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 Key10158214
MDR Text Key223637675
Report Number8010047-2020-03387
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2020
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 Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2020
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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