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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4). (b)(4) checked the subject device found that the reported phenomenon was duplicated, and also that there were some damages on the distal end, the insertion section, and the operating section. Therefore, (b)(4) surmised that the reported phenomenon might be caused by the user handling. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based upon the information from (b)(4), there was possibility that this phenomenon was attributed to the excessive external force applied to the instrument channel port when t-shaped tube (forceps/irrigation plug) was put on and off by the user handling. In addition, omsc confirmed that this phenomenon was not caused by product or manufacture, there were no safety problem, and there was no frequent occurrence. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user facility that during the reprocessing of the subject device at the user facility, it was found that the instrument channel port had been detached. And, as a result of the incoming inspection for repair by a third party, it was confirmed the reported detachment of the instrument channel port. There was no report of patient injury associated with this event.
 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key12016704
MDR Text Key256722070
Report Number8010047-2021-07654
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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