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

Model Number URF-V

Device Problem Poor Quality Image (1408)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the user facility experienced an image difficulty during f-tul (flexible transurethral lithotomy).The facility replaced the subject device with another instrument and the procedure was completed.There was no patient injury reported.

Manufacturer Narrative

The follow-up is being submitted to report the additional information obtained.The device referenced in this report was returned to olympus for evaluation.The evaluation duplicated the reported event and the endoscope image remained blank.When a water leak test was performed, the outer surface of the insertion tube and the instrument channel port were found leaking.When a demo-unit connector was connected, the image remained blank.When the subject device was disassembled, the power supply line of the ccd unit was found corroded and open.The manufacturing record of the subject device was reviewed without irregularity.From the evaluation result, as the probable cause for this event, it is considered that moisture intruded into the inside of the subject device due to leaking and the power supply line of the ccd unit was corroded, then the image became pitch dark because the power was not supplied.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5359523
• MDR Text Key: 36035726
• Report Number: 8010047-2016-00103
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K#:K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: URF-V
• Device Catalogue Number: URF-V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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