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

Model Number URF-V2

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The returned (b)(4) flexible video scope serial (b)(4) was received for evaluation due to "severe damage to insertion portion.Wires exposed".Visual inspection was performed on the received condition and determined that the insertion tube is severely broken below the protector boot which caused the metal coiled mesh to break exposing protruding sharp metal mesh.It was determined that the insertion tube is a non-olympus repair.Based on the device evaluation the cause of the damage to the non-olympus insertion tube is attributed excessive stress and force attributed to mishandling.As a precautionary measure, the instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions for safe use manual indicate 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.

Event Description

It was reported that the scope insertion tube wire is sticking out with severe damage to the insertion portion.No patient/user harm or injury was 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: 9740824
• MDR Text Key: 223448076
• Report Number: 8010047-2020-01478
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2020
• 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