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

Model Number URF-P6R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation. A visual inspection was performed on the received scope and found the scope¿s bending section skeleton tab 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 found to be fully broken and separated with no signs of any sharp edges. The skeleton tab that was protruding from the bending section cover is bent, which is the most probable cause of the skeleton breakage. Based on the investigation, the cause of the broken bending section skeleton and bent skeleton tab is due to excessive force and/or stress attributed to mishandling the instruction manual states ¿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. ¿.

Event Description

The service was informed that during preparation for use, for an unspecified diagnostic procedure, it was observed that the top of the scope¿s bending section was broken. There was no patient involvement and therefore, no patient injury occurred.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8622053
• MDR Text Key: 145517570
• Report Number: 2951238-2019-00848
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/17/2019
• 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: 04/22/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/24/2019
• 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