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

Model Number URF-V2

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed the reported device issue.A visual inspection was performed and found the bending section skeleton broken apart and detached from the insertion tube side causing sharp edges.In addition, the bending section cover was found damaged and causing the charge-coupled device (ccd) wires to be exposed.To add, the scope could not be angulated properly due to the damaged bending section skeleton.The scope was serviced and returned to the user facility.Based on the evaluation results and similar reported events, the cause of the bending section damage is likely attributed to user handling.The instruction manual for use provides warning and caution statements in an effort to prevent scope damage.¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.".

Event Description

Olympus was informed that during an ureteroscopy procedure, the scope was in an acute angle and became stuck inside the patient's kidney.The physician was able to loosen the angulation and successfully remove the scope from the patient; however, the physician was unable to remove the kidney stone and a follow up procedure will take place.No patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to fgb.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6695554
• MDR Text Key: 79738996
• Report Number: 2951238-2017-00440
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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