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

Model Number URF-P6R

Device Problem Fluid Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the manufacturer for service/evaluation. A visual inspection was performed by the service group and noted the bending section cover at the distal end failed the leak test and the bending section skeleton was broken and protruding through the cover. In addition, there was excessive image guide fiber breakage. The scope was last serviced on april 4, 2019. The scope was repaired and returned to the user facility. Based on similar reported events and investigation findings, the potential cause of the broken bending section is attributed to the operator¿s (unintended) technique. The instruction manual warns users "do not twist or bend the bending section with your hands. Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damage. " 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 user facility reported that during reprocessing, the scope was found to leaking at the bottom/distal end. There was no patient involvement with the reported scope.

• 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: 8767231
• MDR Text Key: 150888885
• Report Number: 8010047-2019-02430
• 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

• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/24/2019
• 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