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

Model Number URF-V2R

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was return to olympus for evaluation.The device was visually inspected and found a portion of the bending section skeleton protruding out from the bending section cover near the insertion tube side.The bending section damage is approximately 70mm from the distal end side, which is causing a leak on the bending section cover.The bending section cover was removed in order to reveal the extent of the damage to the bending section.Upon removal of the bending section cover, it was confirmed that the bending section skeleton is fully separated producing sharp edges near the insertion tube side.The condition of the bending section support pins and found, six out of twelve pins receding into the channel and lifting.The instruction manual states the following: ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.The instructions for safe use manual also indicates that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.This file will be updated if additional information is received.

Event Description

The device was returned to olympus for evaluation and service after an air/water leakage and fluid invasion where it was reported that the scope had a visible break in the insulation.No patient involvement was reported.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer confirmed that the likely cause of breakage of the bending section and metallic components protruding from torn bending rubber was unintended use error.

• 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: 10188783
• MDR Text Key: 198860755
• Report Number: 8010047-2020-03605
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1