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

Model Number URF-V2

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the manufacturer for evaluation due to ¿distal end cover damage¿.The manufacturer performed a visual inspection of the device and noted the distal end was broken.The distal end was broken at the base of the bending section area exposing metal.During the inspection there was sufficient evidence of metal protruding outside the bending section cover with no sharp edge.The elements inside the bending section were still connected together regardless of the broken skeleton.The bending section cover was removed and revealed no sharp edges on the bending section skeleton.The instruction manual states, ¿do not twist or bend the bending section with your hands, equipment damage may result¿.The bending section was manipulated; the movement was abnormal due to the broken skeleton.The scope was purchased on (b)(6) 2018 with no previous repair history.The leak test cannot be performed due to the broken bending section.Based on the evaluation by the manufacturer, the user¿s complaint of distal end cover damage was confirmed.The most probable cause of thee broken bending section skeleton protrusion was due to excessive force from mishandling.

Event Description

The manufacturer was informed that there was distal end cover damage with no sharp edges.The device was returned to be investigated for metal protrusion.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 9085034
• MDR Text Key: 218744542
• Report Number: 8010047-2019-03317
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• 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