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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHR
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Event Description
It is reported in mw5101053, after reprocessing a cysto-nephro videoscope, black specks were noted. There is no reported patient contact/impact related to this occurrence. In mw5101053, this facility reports 6 cases. Report with patient identifier (b)(6) reports case 1 of 6 report with patient identifier (b)(6) reports case 2 of 6 report with patient identifier (b)(6) reports case 3 of 6 report with patient identifier (b)(6) reports case 4 of 6 report with patient identifier (b)(6) reports case 5 of 6 report with patient identifier (b)(6) reports case 6 of 6.
 
Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation. Physical evaluation of the complaint device reveals: it was confirmed, the rubber glue was cracked/chipped/peeling. The scope passed the water dunk test. All required repairs were completed and the device was shipped back to the customer meeting safety specifications. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
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Brand NameCYSTO-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
MDR Report Key11957333
MDR Text Key280818091
Report Number8010047-2021-07227
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VHR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No

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