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

Model Number URF-P6

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for an evaluation.A visual inspection was performed on the returned device and found the skeleton is broken about 5mm from the base of the bending section area and is exposing metal outside the cover with no sharp edge.The elements inside the bending section are still connected together regardless of the broken skeleton.Additionally the bending section cover has evidence of stretching at the tip of the distal end.Based on the evaluation, service center was able to confirm the user¿s complaint as the cause to the broken bending section skeleton exposing metal is due to excessive force which is attributed to mishandling.The instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿.The bending section was manipulated and the movement is abnormal due to the broken skeleton at the base of the bending section.The scope purchase resale date was on february 28, 2018 and the last time the scope came in for service was july 3, 2019 for a 28f refurbishment.The leak test cannot be performed due to the broken bending section.

Event Description

The service center received a device for repair for the report of visible damaged along the main stem, the flexible part was crushed.No other event information has been provided by the user facility.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 8848424
• MDR Text Key: 216316860
• Report Number: 8010047-2019-02773
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/31/2019
• 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