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 device was returned to the service center for evaluation.A visual inspection was performed on the received device and found that the bending section cover had no signs of metal protruding.The bending section cover was removed and found the bending skeleton broken, which most likely was caused the cut on the bending section cover.The bending section skeleton tab was fully broken/detached at the insertion tube area.Additionally, there were no sharp areas noted with the broken/detached skeleton.The scope failed the leak test due to leaking from the bending section cover, there is a cut on the bending section cover that cause the leak.A review the instrument history was performed and found the scope was returned for service and was overhauled on may 13, 2019.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 damage.¿.

Event Description

The service center was informed that the scope¿s distal tip is broken.No further information was provided.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8708453
• MDR Text Key: 148324442
• Report Number: 2951238-2019-00954
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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: 05/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• 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