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

Model Number URF-V2

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 02/17/2018

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.(omsc) and it is under evaluation.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during an tul (transurethral ureterolithotomy) procedure, the user felt abnormality with the bending section, and the subject device was removed from the patient ureter.The user found the bending section breakage.Then the user replaced the subject device with an uretero-reno video scope (urf-v manufactured by olympus) and completed the procedure.There was no patient injury associated with this event reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.This device referenced in this report was returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation, a fracture of the bending tube of the subject device was confirmed.It was also confirmed that there was a pinhole in the instrument channel of the subject device.In the past causal investigation by omsc, it was confirmed that the bending tube breakage occurred when urf-v2 was repeatedly pushed against the wall under the condition that the tip of urf-v2 was in contact with a kidney wall.Therefore, it is considered that the bending tube breakage of this report possibly occurred by the same mechanism.The instruction manual contains several statements in an effort to prevent bending section damage.¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ ¿do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.¿.

• 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
• MDR Report Key: 7333292
• MDR Text Key: 102454959
• Report Number: 8010047-2018-00428
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

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: 03/07/2018
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1