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

Model Number URF-V2R

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, multiple follow ups to the user facility were made by telephone and in writing in an attempt to gather additional information on the reported event; however, no further information was obtained.A review of the service history indicates the scope was purchased on (b)(6) 2018 and has received service via three repairs in the past two years.The scope was last repaired on (b)(6) 2019 for a kinked/broken bending section.(b)(4) a visual inspection was performed on the scope and noted the metal bending section skeleton tab was protruding from the bending section cover near the insertion tube area.The bending section cover and the bending section skeleton were fully broken and separated with no signs of any sharp edges.The insertion tube on the scope was a third party repair/part.There were also third party repairs noted with the bending section cover/glue and protector boot.The image on the scope is flickering and the up/down angulations on the scope are low.Based on the evaluation results, the most probable cause of the broken bending section can be attributed to (unintended) operation error or from improper maintenance.To mitigate the risk of equipment damage the instruction manual states, "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 damage.".

Event Description

The service center was informed that during reprocessing, the scope was found to have a bent distal end.There was no patient injury reported.

• 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: 9769311
• MDR Text Key: 221570975
• Report Number: 8010047-2020-01556
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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: 02/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• 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