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

Model Number URF-V2

Device Problems Leak/Splash (1354); Component Missing (2306); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to service center for an evaluation and the user¿s complaint has been confirmed.A visual inspection was performed and found the bending section skeleton protruding out from the cover.The bending section damage is approximately 70mm from the distal end side which is also causing a leak.The bending section cover was removed in order to reveal the extent of the damage.The bending section skeleton is fully separated producing sharp edges near the insertion tube side.The condition of the bending section support pins was also checked and found eight out of the twelve pins receding into the channel.The instruction manual states the following warnings; ¿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 and this would occur more so in a narrow environment.Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling.

Event Description

The service center was informed that the device distal end was missing the rubber.The device was received for repair and found a-rubber has been torn by sharp edges of broken skeletons and lifted support pins on bending section.It was also noted the device has instrument channel leakage.

• 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: 8884815
• MDR Text Key: 154392829
• Report Number: 8010047-2019-02936
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: 07/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2019
• 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