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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. During the evaluation the device was leak tested and no leaks were observed. The reported issue was confirmed, the scope had a hole in it and the cap was broken. A replacement device was shipped to the user facility. In addition, as part of the investigation into this report,olympus followed up with the user facility to obtain more information and was informed the issue was noticed during reprocessing. The scope was taken out of the sterilizer and it was noticed that when they opened the cap the end of the scope had blown out. The cap was still on the scope. However, when they opened the cap it was noticed the camera part had blown out. A new cap has been ordered. The device has been sent to olympus for repair. No other damage or abnormalities were observed when the scope was inspected after the two issues were noticed with the scope. The service order number is (b)(4). There was no patient involvement. This one scope was the only one that had damage. The sterilizer being used is an asp sterad x. This sterilizer is new. The scopes are leak tested prior to every procedure. The leak tester is an olympus leak tester model wa23080a. Enzymatic detergent is being used to manually clean and disinfect the scopes. It is unknown how often the minimum effective concentration is being checked. The endoscope channel is being brushed with an olympus bw-7b brush. Pre-cleaning is being done immediately after a procedure. Air is flushed into the endoscope. The last time a reprocessing in-service was provided was 3 years ago. However, their processing and infection control come every year to watch them clean the scopes. All reprocessing personnel are trained on how to reprocess the scopes. The scopes are being stored in their sterile container when not in use. The user facility continues to reprocess the scopes following manual instructions. If additional information is obtained a follow up report will be submitted.

 
Event Description

The user facility reported that parts fall off from the distal end of the scope. The scope has a hole, and the eto cap was broken.

 
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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
kenneth pittman
2400 ringwood avenue
san jose, CA 95131
9013785969
MDR Report Key10201296
MDR Text Key199723394
Report Number2951238-2020-00460
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/26/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated By Manufacturer? Yes
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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