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Model Number CYF-VH
Device Problems Break (1069); Collapse (1099); Loose or Intermittent Connection (1371); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem Injury (2348)
Event Date 07/05/2017
Event Type  Injury  
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
Manufacturer Narrative
The device referenced in this report has not been returned to olympus medical systems corp. , but returned to olympus keymed (okm) with the leakage tester (mb-155) attached to the subject device. During the investigation, the leakage tester could be removed after conducting leak test. The reported phenomenon was not duplicated. The investigation found followings: -the venting connector was loose. -there was crush marks on the bending section. -the light guide was damaged. -there was delamination on the universal cord. -the angle of up angulation was out of standard. There was no irregularity when attaching and detaching the connector to the venting valve, however it was found that the venting valve rotated approximately 10 to 15 degree when the leakage tester was connected and applied sufficient force. Okm determined that the movement might not be directly attributed to the reported phenomenon. Okm attached the leakage tester to multiple devices and confirmed the leakage tester was fully operational. The subject device was sold on august 21, 2015, and the last service was to replace the distal end on january 5, 2017, due to no image. The manufacturing record of the subject device was reviewed with no irregularity. The exact cause could not be concluded at this moment. If additional and significant information becomes available, this report will be supplemented.
Event Description
Olympus was informed that the connector cap of the leakage tester (mb-155, olympus) was too hard to remove from the venting connector of the subject device, and the venting connector was regularly out of alignment. When this event occurred, the connector cap of the leakage tester was stuck at the venting connector of the subject device and the user could not remove it. When the user was trying to remove the leakage tester from the subject device, the user injured with blister and cut on her thumb. The medical intervention was not required for the injury. While the olympus personnel was at the user facility, the other scope came in and it was hard to remove the leakage tester from the venting connector, but the user and the olympus personnel somehow removed it. This phenomenon had been occurring regularly for about 2 years since the user purchased the scopes. The user assumed that the cause was in the leakage tester, and the user has replaced leakage tester about 6 times. However, same phenomena have been occurred.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
MDR Report Key6762729
MDR Text Key249392757
Report Number8010047-2017-01138
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2015
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: 08/03/2017 Patient Sequence Number: 1