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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-VHA
Device Problem Fail-Safe Problem (2936)
Patient Problem Blood Loss (2597)
Event Date 05/23/2017
Event Type  Injury  
Manufacturer Narrative

The subject device was returned to omsc. The evaluation of the subject device by omsc confirmed following defects. - there were kinked and sneaky on the bending section. - there were cracked and scratches on the rubber of the bending section. The phenomenon did not reproduce. The exact cause of the reported phenomenon could not be determined conclusively at present.

 
Event Description

Olympus medical systems corp. (omsc) was informed that during the examination, the bending section of the subject device was angulated and the doctor couldn't release the angle. The doctor anesthetized additionally. It took two hours to withdraw the subject device from the patient. There was slight bleeding during withdrawing the subject device. Although there was slight bleeding and the patient's blood pressure had risen, doctor judged that there was no need for taking medical treatment. In 2014 the patient underwent surgery to remove the prostate completely. And the urethra was confirmed to be stricture during the follow-up diagnosis. The doctor informed the following. - there was no abnormality in the bending section of the subject device during inserting it. - the doctor didn't confirm whether angulation lock was engaged.

 
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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
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6659487
MDR Text Key78135754
Report Number8010047-2017-00766
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VHA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/09/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/22/2017 Patient Sequence Number: 1
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