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

Model Number URF-P6R

Device Problems Break (1069); Melted (1385); Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

The reference device was returned to service center for an evaluation.A visual inspection was performed and found the bending section skeleton protruding out from the cover.The bending section damage is approximately 70mm from the distal end side, which is also causing a leak.The bending section cover was removed in order to reveal the extent of the damage.Upon removal of the cover, it was confirmed that the bending section skeleton is fully separated producing protrusion near the insertion tube side.The bending section support pins are still intact and not lifting.Further findings include a burn on the distal end body, leak from the distal end body, and broken fibers scattered throughout the image.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress attributed to mishandling.Followed up with the user facility in writing to obtain additional information regarding the reported event was performed multiple times with no additional information to date.The instruction manual states the following warnings statements; ¿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 in a narrow environment".

Event Description

The customer returned the scope indicating the image was black during the procedure.No other details have been provided.This report is being submitted based on the service findings of the distal end rubber leakage and the bending section found broken with the metal exposed and protruding.

• 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: 8828030
• MDR Text Key: 152824533
• Report Number: 8010047-2019-02708
• 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: 07/25/2019

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/25/2019
• 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