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 scope was returned to olympus for evaluation. The evaluation confirmed the reported event as a visual inspection was performed and the bending section skeleton was found broken; located approximately 75mm from the distal end side. The bending section cover was received separated (torn) from the glue on the insertion tube side, exposing the broken bending section skeleton. The bending section skeleton is fully broken with sharp edges adjacent to the insertion tube. The bending section tab was lifting at the same location. A review of the scope's instrument history record showed the scope was purchased on (b)(6) 2018 and was last serviced by olympus on (b)(6) 2018. Based on similar reports related to the reported event and reported device, the likely cause of the could be attributed to the operator¿s technique. The instruction manual states the following; ¿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 so in a narrow environment. Limited information was provided by the user facility. As part of our investigation, multiple follow ups were made in telephone and in writing to obtain additional information regarding the reported event but no information was obtained. However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that the bending section was broken. There was no patient involvement reported with the subject 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8346361
• MDR Text Key: 137254764
• Report Number: 2951238-2019-00438
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/15/2019
• 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: 01/24/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/27/2019
• 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