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

Model Number URF-V2

Device Problems No Display/Image (1183); No Device Output (1435)

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

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report was returned to olympus medical systems corp.For evaluation.During the evaluation, the reported phenomenon duplicated.It was also confirmed that there were corrosion at the distal side of the instrument channel and fluid mark inside the grip section, scrape and curling up of inside wall on the instrument channel.The manufacturing record of the device was reviewed without irregularity related to this event.The exact cause of the reported event could not be conclusively determined however, a short circuit due to the fluid ingress will be a possible cause for the event.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the image loss of the subject device occurred during an unspecified procedure.The subject device was replaced with a urf-p5 (uretero-reno fiberscope, manufactured by olympus) and the procedure was completed.There was no patient injury reported.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6773014
• MDR Text Key: 83746380
• Report Number: 8010047-2017-01187
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1