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

Model Number URF-V

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

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus for evaluation.As it was reported, the phenomenon was duplicated that the subject device did not display image.There were such a burnt trace as a laser and a water leakage in the instrument channel at the distal end of the subject device.The user facility commented that they did not conduct an inspection before use.The user facility commented that the endoscopic image was lost during emitting laser.In addition, there was a burnt mark around opening of the instrument channel.Therefore, the user facility emitted laser by mistake, which might cause overload for charge coupled device (ccd), and consequently, the image loss might occur.The manufacturing record of the subject device was reviewed with no abnormality possibly associated with the reported phenomenon.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the video image of the subject device was lost during a trans urethral lithotripsy procedure.The procedure was completed with another device.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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6427052
• MDR Text Key: 70636258
• Report Number: 8010047-2017-00328
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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