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

Model Number URF-P6R

Device Problem 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 the service center for a physical evaluation. A visual inspection was performed on the returned device and found the bending section skeleton tab was protruding (sticking out) from the bending section cover near the insertion tube area. The bending section cover was removed and the bending section skeleton was fully broken and separated with no signs of any sharp edges. The protruding skeleton tab was bent. The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿. 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. This is a newer type ns unit (post counter measure) that was verified by the positioning of the bending section tab. The scope had a 28f (overhaul) on 6/25/2019 from the previous repair. Based on the evaluation, the cause of the broken bending section skeleton and bent skeleton tab is due to excessive force and/or stress attributed to mishandling.

Event Description

The scope was returned to the service center for a poor image. During the service estimation the metal protrusion at the bending section of the scope was found. No other details were made available.

• 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: 8861153
• MDR Text Key: 194324748
• Report Number: 8010047-2019-02836
• 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

• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/05/2019
• 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: 07/05/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/08/2019
• 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