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

Model Number URF-P6

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service for evaluation.The reported broken fibers was confirmed as 20+ black dots were found on the image; indicating excessive broken image guide fibers.A visual inspection of the scope found the bending section skeleton tab is protruding out from the bending section cover near the insertion tube area.The bending section cover was removed and the bending section skeleton is fully broken, separated and cracked with sharp edges on the surface of the breaking point.In addition, there is passage restriction in the instrument channel.The scope failed the leak test from the bending section and from the instrument channel.A review of the instrument history indicated the scope was previously repaired on april 16, 2019.Based on the evaluation the most probable cause of the broken image fibers and the broken bending section skeleton is attributed to (unintended) excessive stress and force applied to the bending section area.Insufficient information was provided by the user facility.Multiple follow ups were made to obtain additional information from the user facility but with no results.However, if additional information becomes available, this report will be supplemented accordingly.The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury.¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient.If the up/down angulation control lever does not move.If the angulation control mechanism is not functioning properly.Visually inspect the bending section for no metallic parts protruding from the bending section.Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.Visually inspect the bending section for abnormal bending shape, or other irregularities.Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.".

Event Description

The manufacturer was informed that the image of the scope has broken fibers.There was no serious injury or death reported.

• 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: 8837142
• MDR Text Key: 216104052
• Report Number: 8010047-2019-02726
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2019
• 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