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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.For evaluation.The evaluation found that the phenomenon was reproduced.The subject device failed the water leak test due to the pinhole in the instrument channel.There were scratches on the inner wall of the instrument channel.The manufacturing record of the subject device was reviewed with no abnormality possibly associated with the reported phenomenon.The exact cause of the reported event could not be conclusively determined however, it will be a possible cause that water or chemical solution intrudes into the subject device and the image unit was short-circuited as a pinhole was found in the instrument channel.

Event Description

Olympus was informed that during an endoscopic treatment of the ureter, the image of the subject device disappeared.When the user facility turned on the power again, the error message of communication between a scope and a video system center was displayed.The subject device was replaced with an unspecified device 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 ; 8142642517
• MDR Report Key: 6502674
• MDR Text Key: 73094448
• Report Number: 8010047-2017-00465
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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: 04/05/2017
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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