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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 Problems No Display/Image (1183); Material Twisted/Bent (2981)
Patient Problems Tissue Damage (2104); Blood Loss (2597)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative

The referenced scope was returned to the service center for evaluation. A visual inspection was performed on the received condition and found the bending section at the distal area was dented/kinked near the middle portion. The damage to the bending section is located at approximately 40mm from the distal end side. The image of the scope was inspected by connecting the video scope to a test cv-190 processor and clv-190 light source; with no image anomalies (flickering, loss of image) observed. During the image inspection, the bending section, insertion tube, light guide tube and video cable were periodically manipulated in attempt to replicate a loss of image, which never presented itself. The instrument channel was found twisted and collapsed at the same location of the external damage to the bending section area. Due to the collapse of the bending section and biopsy channel, the brush and forceps are unable to pass through the channel. Furthermore, the scope passed the leak test. Additionally, the bending section cover glue on both ends of the bending section cover were noted as chipped, peeling with some missing bending section cover glue pieces. The light guide tube, video cable and protector boots have various areas of discoloration. Based on the evaluation findings and the information reported, the most probable cause of the bending section damage is due to excessive force. The instruction manual provides warning to mitigate the risk of patient injury and damage to the device. Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination. Do not pull the universal cord and video cable during an examination. The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.

 
Event Description

The manufacturer became aware that during procedure, the doctor inserted the endoscope into the patient's urethra and lost view and went withdraw the endoscope. The endoscope got stuck and became kinked and folded over. The doctor was eventually able to withdraw and straighten the endoscope. As a result, the patient suffered bleeding, urethra trauma and the patient had to be cauterized.

 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9146191
MDR Text Key167086449
Report Number8010047-2019-03455
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2019
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

Patient TREATMENT DATA
Date Received: 10/02/2019 Patient Sequence Number: 1
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