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

Model Number URF-V3

Device Problem Image Display Error/Artifact (1304)

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

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the endoscopic image of the subject device became abnormal during a therapeutic ureterorenoscopy procedure under general anaesthesia.The user facility reported that the abnormal image occurred when they changed a cystoscopy to the ureterorenoscopy using the subject device.The user facility tried to resolve the abnormal image by changing and adjusting the settings of the monitor different ways, but the image did not recovered.Since the user facility had no alternative device for the procedure immediately, they stopped the intended procedure.The procedure was re-scheduled in the next day.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).During the evaluation by (b)(4), the reported abnormal image was duplicated.However, (b)(4) could not found any other abnormalities such as physical damage in the device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result for the subject device by olympus medical systems corp.(omsc).This device was returned to omsc for evaluation.During the evaluation, the reported abnormal image was duplicated.The appearance and soldering condition of the signal cable around the ccd (image unit) was evaluated under x-ray, but there was no abnormality in them.However, abnormal resistance value of the signal cable connected to the ccd was confirmed.Based on the evaluation result, it was concluded that the reported abnormal image was due to the break of the signal cable connected to the ccd.However, the cause of the disconnecting of the cable could not be 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
• MDR Report Key: 8178133
• MDR Text Key: 131158134
• Report Number: 8010047-2018-02481
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1