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

Model Number URF-V2

Device Problems Break (1069); Material Rupture (1546); Cut In Material (2454)

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

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation, a split in the bending rubber and a rupture of the bending tube of the subject device were confirmed.As the bending tube was ruptured diagonally, the stress to the bending tube might be from right or left side of the bending tube.The manufacturing record of the subject device was reviewed with no irregularity.It might be a possible cause for the split of the bending rubber that the subject device was inserted / withdrawn while calculus was contacted with the bending rubber.From our causal investigation result, it was confirmed that under the condition where the distal end of the scope comes in contact with an inner wall of a kidney, if the scope is repeatedly further pushed, the bending tube breakage occurs.Therefore, the bending tube breakage in this report is considered to have occurred in the above 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.¿.

Event Description

Olympus medical systems corp.(omsc) was informed that during an f-tul (flexible transurethral ureterolithotomy) procedure, the user found a split in the bending rubber of the subject device.It was also reported that there was no parts dropped off into the patient.The user replaced the subject device with another device and completed the procedure.There was no patient injury associated with this event 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: 7265879
• MDR Text Key: 100264160
• Report Number: 8010047-2018-00216
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: 01/22/2018
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1