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

Model Number URF-V2

Device Problems Poor Quality Image (1408); Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa (b)(4).(b)(4) evaluated the subject device and confirmed as follows: there was an air leak from the bending section rubber.A part for guiding of angulation wire (cable support) was detached from the bending section tube within the bending section rubber.Horizontal lines were displayed on the endoscopic image of the subject device.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Although the exact cause of the reported event could not be conclusively determined, but it was surmised that the reported event occurred by abnormality in the electrical image unit (ccd) due to water invaded through the leakage in the bending section rubber.If additional information becomes available, this report will be supplemented.The instruction manual of the device instructs: if air bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope.Water may enter the endoscope and cause a short circuit.This may result in image sensor damage.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility noticed that the endoscopic image of the subject device was unstable when connecting the subject device to the trolley (unspecified light source, video system center, and monitor) before a retrograde intrarenal surgery.The user facility changed the subject device and completed with another flexible ureteroscope.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: 8397478
• MDR Text Key: 140014066
• Report Number: 8010047-2019-01205
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• 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