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

Model Number URF-V2R

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.A visual inspection was performed and noted a cut as well as a sharp metal tab protruding through the bending section cover.Upon removal of the bending section cover, the sharp metal tab was found lifting.The scope was serviced and returned to the user facility.Based on the evaluation, the user¿s complaint was confirmed.The cause for the broken insulation exposing metal is due to excessive force which is attributed to mishandling.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 is abnormal due to the broken skeleton at the base of the bending section.The scope resale is on (b)(6) 2019 and the last time the scope was returned for service was august 29, 2019 for a full refurbishment.The leak test cannot be performed due to the scope¿s broken bending section.

Event Description

The service center was informed that during reprocessing, the scope was found to have a broken insulation and visible wires.There was no patient injury 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: 9330819
• MDR Text Key: 219764186
• Report Number: 8010047-2019-03991
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• 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