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

Model Number URF-V2

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4).In the confirmation at the service station of osh, the reported phenomenon was duplicated.In addition, the following were confirmed; failure of the remote switch.Scope communication error e30.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the image of the subject device became black and white stripes at pre-use inspection at the user facility.The user facility canceled the procedure.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to additional information.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.The exact cause could not be determined, but it was surmised that the phenomenon occurred due to ccd damage from the result of confirmation by osh.Ccd damage may have occurred due to excessive bending and tensile stress applied to the distal end and the bending section where the ccd was built.The instruction manual of the subject device already instructs; follow the warnings given below.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result.If any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.

• 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
• MDR Report Key: 8796819
• MDR Text Key: 151315911
• Report Number: 8010047-2019-02552
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1