MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

A distributor confirmed the phenomenon that the power of the otv-s190 failed at the user.And also, an electronic shutter automatically worked without manipulating.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be determined at present, because the subject device is under the investigation.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that during an unspecified procedure using the subject device, the video system center (otv-s190) shut down.The user judged that the system center was abnormal, and replaced the otv-s190 with another one.The same phenomenon occurred several times after replacing the otv-s190, so the user resupplied a power source of the otv-s190 whenever the phenomenon happened.The user continued the procedure, and completed it.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation of the subject device by omsc confirmed following: the phenomenon reported from user facility did not reproduce.The remote switch 3 did not work.A water leakage test was failed and there was a pinhole inside of the biopsy channel.There were scratches near the bending section inside of the biopsy channel.The inside of the control section was corroding due to invasion of chemical solution or water.It was not unknown whether the above failures contributed to the reported malfunction or not.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO 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 ; 426425177
• MDR Report Key: 6992564
• MDR Text Key: 92068860
• Report Number: 8010047-2017-01621
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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