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

Model Number URF-P6R

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found the bending section broken at approximately 75mm from the distal end.Prior to removal of the bending section cover, it was verified that there were no signs of the bending section skeleton protruding.The bending section cover was then removed to determine the reason for the bending section irregularity.Upon removal of the bending section cover, it was discovered that the bending section skeleton was partially broken with sharp edges adjacent to the insertion tube.The bending section skeleton tab is also bent causing it to lift at the same location where the bending section is broken.Additionally, an olympus "boroscope" was used to inspect the channel and noted numerous tear marks located within the bending section area, which also included a section of the biopsy channel that was found to be deformed.The scope¿s image was also inspected and found ig damage in the form of excessive broken fibers which cover 80 percent of the image and are within the field of view.A review of the scope's instrument history record showed the scope was purchased on (b)(6) 2018 and has not been returned for service/repair since the date of purchase.Based on similar reports related to the reported event and reported device, the likely cause of the could be attributed to the operator¿s technique.The instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.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

Olympus was informed that during a diagnostic urology procedure, the scope¿s bending section broke.There was no bleeding observed.The intended procedure was completed with the same device.The patient was discharged home in good condition.Additionally, the user facility reported that the scope was inspected post procedure by the reprocessing technician with no visual deformation noted on the bending section of the scope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem).As part of our investigation, the oem reviewed the content of this complaint and reported that due to no device return a root cause for the reported event cannot be determined.The oem performed a dhr review and found no anomalies during the manufacturing of this device.

Manufacturer Narrative

This supplemental report is being submitted to correct section b1.

• 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: 8355536
• MDR Text Key: 139587648
• Report Number: 2951238-2019-00447
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: 01/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1