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

Model Number URF-V2R

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation.The returned urf-v2r flexible scope (serial# (b)(4)) was evaluated due to ¿failed the leak test¿ issue.The reported complaint was confirmed.A visual inspection was performed on a received condition and determined that a small portion of the bending section cover is torn, missing and exposing the bending section skeleton.The rest of the bending section cover was removed and determined the bending section skeleton tab was fully broken/detached at the insertion tube area.However, during inspection , there was no significant evidence of sharp edges observed with the broken/detached skeleton.As preventive measure, in the instruction manual it states that ¿do not twist or bend the bending section with your hands.Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged".Additionally, there is also a leak inside the biopsy channel due to tear/torn marks on the channel wall at the distal end side.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.

Event Description

It was reported that during the leak testing, it was determined that the scope failed the leak test.It was due to the a-rubber being torn by sharp edges from a broken bending section.Metal was exposed with channel leaking.There was no patient involvement and no user harm or injury reported due to 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: 9290192
• MDR Text Key: 195078936
• Report Number: 8010047-2019-03885
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1