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

Model Number URF-V

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to ofr for repair.Ofr partially disassembled and inspected the device, and confirmed the following; there was leaked at the bending section rubber due to the perforation.There was humidity inside the control section and the insertion tube, and the electrical contacts of the video connector were corroded.There were rusty deposits in the circuit board of the device's metal plug.There was a impact trace in the bending section.The bending section does not move downward when operating the angulation control lever.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 inspected the device at the service department of olympus (b)(4) (ofr) and found that the bending section rubber of the device was burnt and torn by laser irradiation, and the metal was sticking out at the damaged area.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp.(omsc) and the repair history could not be confirmed.The device was manufactured on march 6, 2017 and about three years and nine months have passed, but it was unknown whether the bending tube damage was affected by aging.Therefore, omsc determined that the reported event may have been caused by an external force on the bending tube.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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: 11070477
• MDR Text Key: 228023388
• Report Number: 8010047-2020-10936
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1