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

Model Number URF-V

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation by omsc, the reported endoscopic image loss was not duplicated.The evaluation confirmed a leakage from the instrument channel of the device.In addition, it was confirmed that there were multiple peels on the inner surface of the instrument channel.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Considering the evaluation result, it was surmised that the reported event occurred by short circuit around the electrical image unit (ccd) due to water invaded through the leakage of the instrument channel.The leakage of the instrument channel was possibly caused by interference of endo therapy accessories.The instruction manual of the device instructs; be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism or other malfunctions and poses an infection-control risk.

Event Description

Olympus medical systems corp.(omsc) was informed that during an unspecified procedure, the endoscopic image of the subject device disappeared.The user facility changed the subject device and the procedure was completed with another device.There was no report of patient injury associated with the event.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8427830
• MDR Text Key: 139249506
• Report Number: 8010047-2019-01308
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• 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: 02/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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