MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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

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.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6762729
• MDR Text Key: 81719577
• Report Number: 8010047-2017-01138
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• 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 Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other