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 for service to evaluate the reported ¿broken bending skeleton, damage distal tip¿.A visual inspection was performed on the bending section cover and was unable to find any signs of protruding from the bending section cover and the scope passed the leak test.However, the bending section skeleton was observed to be deformed underneath the bending section cover.The bending section cover was removed and the bending section skeleton tab was fully broken/detached at the proximal side of the bending section.Additionally, there was no significant evidence of sharp areas noted with the broken/detached skeleton.Based on the evaluation and similar reported events, the cause of the broken skeleton is due to excessive stress and force.A review of the scope's records indicate the scope was purchased on (b)(6) 2018 with no repair history.To mitigate the risk of patient injury and device damage the instruction manual it states, ¿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.

Event Description

The service group was informed that prior to a procedure, the scope was observed to have a broken bending section.There was no patient injury reported as the scope was not used during procedure; no patient contact.

• 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: 9194641
• MDR Text Key: 219785566
• Report Number: 8010047-2019-03586
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/15/2019
• 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
• Patient Sequence Number: 1