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

Model Number URF-P6R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation.The returned urf-p6r flexible scope (serial#(b)(4) was evaluated due to ¿broken, damage distal end ¿issue.A visual inspection was performed on a received condition and determined the bending section skeleton is protruding (sticking out from) the bending section cover near the insertion tube side.Leak testing was performed and failed due to the protruding skeleton tab.The bending section cover was removed, found that the bending skeleton was fully broken and separated with no signs of any sharp edges.In addition, an excessive broken fibers on the image was observed due to the broken skeleton.In summary, based on the evaluation, the likely cause of the broken bending section skeleton is due to mishandling.The broken fibers were attributed to the broken skeleton.As a precautionary measure, the instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.The instructions for safe use manual also indicates 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

It was reported that the scope distal end has breakage and a sharp edges protruding metal were observed.It is unknown if the issue was found during a case or during the reprocessing however, no harm or injury reported due to the event.Follow ups were made to obtain additional information regarding the reported event however, no response is received from the customer.

• 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: 9666842
• MDR Text Key: 221016513
• Report Number: 8010047-2020-01095
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2020
• 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