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

Model Number URF-P6R

Device Problems Fracture (1260); Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the bending section of the device was found to be broken with a pin sticking out.The cause cannot be conclusively determined.

Event Description

It was reported that during preparation for use, the device produced a cloudy image.No additional information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information (h10) regarding the reported event.Device evaluation identified the pin was protruding from the distal sheath of the bending section.The bending section does not move even when the angle lever is moved.Chipping, peeling, falling off of the distal end/gluing part of bending rubber.The black shadow appears on the image and the image was obstructed during the procedure was caused by a broken fiber.There was noted a water/air leak from the distal end as well as from the insertion port/ bending section.Although the definitive cause of the reported event cannot be established, it is judged the bending tube being kinked/broken was caused by excessive pushing force was applied while the bending section was bent when inserting into urinary tract or lower kidney calyx.Per the instructions for use: never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result.It may also become impossible to straighten the bending section during an examination.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• 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
• MDR Report Key: 10075813
• MDR Text Key: 222564843
• Report Number: 8010047-2020-02815
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1