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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

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SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VA2
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The olympus representative reported (on behalf of the customer) that the visera cysto-nephro videoscope presented with air/water leakages.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted that there were defects in the channel due to stress.This report is to capture the reportable malfunctions of the channel defects noted at estimation.
 
Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: insufficient angle; distal sheath was creased; insertion tube collapse, with scratches and wrinkles; universal cord was crushed and scratched, video cable crushed and scratched; chipping of distal sheath; video connector, video connector case, light guide connector scratch, light guide cover glass scratch; video connector contact peeling; operation part scratch, switch box scratch, grip scratch, angle lever scratch, up/down plate scratch, up/down angle fixing lever scratch; operation part index peeling, switch-box paint peeling, up/down plate paint peeling; and poor water tightness at the tip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported the visera cysto-nephro videoscope is used 10 times per week.The subject device is cleaned used an oer-4.
 
Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely that the handling of the device caused shaving of the forceps plug cap.A final root cause of this event was unable to be identified.The event can be prevented by following the instructions for use which state: ¿do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.The endoscope¿s remote switches cannot be removed from the control section.Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks.¿ olympus will continue to monitor field performance for this device.
 
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Brand Name
VISERA CYSTO-NEPHRO VIDEOSCOPE
Type of Device
CYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16402341
MDR Text Key310242037
Report Number3002808148-2023-01576
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170339455
UDI-Public04953170339455
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-VA2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2023
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
OTV-S190, CLV-S190
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