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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 Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to the service center for evaluation. The customer¿s complaint of missing rubber and leaking was confirmed. The evaluation noted a dent on the scope¿s cover, cracked glue and missing color code on the control body. The scope was repaired and returned to the customer. The instruction manual provides a warning statement to prevent physical damage. Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient.

 
Event Description

The service center was informed that a portion of the scope¿s bending section rubber was missing during reprocessing. As a result, the scope failed leak testing. There was no report of patient involvement or patient injury.

 
Manufacturer Narrative

This supplemental report is being submitted to provide additional information. The legal manufacturer reviewed the contents of this complaint. As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession and variation. The legal manufacturer reported that the root cause could not be determined. The legal manufacturer reported that the most probably cause for the reported event is the following: the likely cause of the bending section rubber coming-off (breakage). An external force was applied to the bending section, which might have caused the rubber to come off due to the breakage; age deterioration caused the breakage; or both of the above might have caused the indication phenomena nine years and six months have passed since the subject device was manufactured the leak occurred possibly due to the following below: (1)missing bending rubber could have caused leaks from the actual device.

 
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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 Key10258507
MDR Text Key222938076
Report Number8010047-2020-04151
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 12/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received11/18/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/19/2011
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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