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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

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SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2023
Event Type  malfunction  
Event Description
The customer reported to olympus that the oes cystonephrofiberscope had the rubber gasket at the base of the forceps plug rise, causing intermittent air flow.The issue was found during reprocessing with the procedure being completed.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: the forceps mouthpiece was dislodged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
 
Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the forceps mouthpiece was dislodged.The following non-reportable malfunctions were found during the device evaluation: there was insufficient curvature angle, forceps insertion and insertion of cleaning brush.There were flaws in the adhesion of the curved rubber, scratches on the actuator, grip, air vent, eyepiece and fixing ring.The eyepiece was leaking liquid, the image guide bundle had a stain, the light guide mounting clasp was rattling, the actuator was corroded and leaking grip liquid.The up down plate was leaking liquid.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b3 of the initial medwatch.The information was inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to physical stress.Olympus will continue to monitor field performance for this device.
 
Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's re-evaluation of the subject device and findings.There were no significant breakage traces, such as a pit or a defect on the forceps plug hole.And the adhesion of the forceps plug rubber packing was peeled off.Therefore, it is possible, that the stress was applied to the forceps plug hole when the t-shaped tube was detached from the forceps plug hole.Resulting in the rubber packing at the root of the forceps plug being raised and detaching the forceps plug hole.It is likely, that the forceps cap was damaged, so water tightness could not be maintained.Resulting in air leakage.Olympus will continue to monitor field performance for this device.
 
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Brand Name
OES CYSTONEPHROFIBERSCOPE
Type of Device
CYSTONEPHROFIBERSCOPE
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 Key18097491
MDR Text Key328499899
Report Number3002808148-2023-12499
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170339424
UDI-Public04953170339424
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K032092
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,Followup
Report Date 01/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCYF-5A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/24/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received11/13/2023
12/15/2023
Supplement Dates FDA Received11/28/2023
01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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