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

Model Number URF-V2

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to service center for an evaluation.A visual inspection identified the instrument had a broken bending section and metal protrusion from the a-rubber.The instrument channel had leakage and the angulation was deformed.There was sufficient evidence of metal protruding outside the bending section cover but no sharp edge was identified.The elements inside the bending section are still connected together.According to the instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿.The bending section was manipulated and the movement is abnormal due to the broken skeleton at the base of the bending section.The leak test cannot be performed due to the broken bending section.Based on the evaluation service center was able to confirm the user¿s complaint as the cause to the broken bending section skeleton exposing metal is due to excessive force which is attributed to mishandling.

Event Description

The scope was returned to service center for an estimation related to a leak test failure.A leak test was being performed after each use of the scope.The service center noted the a-rubber was punctured by sharp edges from the broken bending section with metal protruding.There were no patient injuries reported.

• 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: 8940782
• MDR Text Key: 215569291
• Report Number: 8010047-2019-03105
• 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: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2019

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/28/2019
• 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