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

Model Number URF-P6

Device Problems Break (1069); Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint of ¿broken fibers¿ was confirmed as excessive broken fibers were found in scope¿s image.Also found broken skeleton of the bending section which damaged light guide bundles and broken fibers.The metal part of scope¿s skeleton ring was sticking out of the pinhole in the bending section rubber.A leak was noted at the bending section rubber after it was taped and at scope¿s control body seam.There was also, discoloration and corrosion noted on the control body of the scope.The scope¿s angulation was tested and found to be low.In an effort to prevent bending section damage, the instruction manual of the device contains several statements; ¿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

The service center was informed that there were guidewire issues and broken fibers on the scope.There was no patient involvement reported.

Manufacturer Narrative

The legal manufacturer reviewed the contents of this complaint.As the result of dhr review, it was confirmed that the subject device was shipped in accordance with specifications.The legal manufacturer reported that the root cause could not be determined.The legal manufacturer reported that the most probably cause for the reported event is the following: the cause of this event was determined as breakage of the bending tube.Although the cause of breakage of the bending tube was not identified, a way of handling the endoscope as mentioned below was determined as a cause.The legal manufacturer reported that if the user follows the ifu ¿instructions for safe use¿, damages in the bending tube can be eliminated.However, there is a possibility of deviation of the user¿s usage from the instruction.If when the endoscope is inserted into the lower kidney calyx or urinary tract and the endoscope is excessively pushed while its bending section is bent.The legal manufacturer performed a complaint history check for this customer and found a previous event for the same phenomenon.As a result the legal manufacturer performed an instrument history review and found that the customer¿s scope had undergone multiple overhaul repairs on the following dates: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10659180
• MDR Text Key: 214643833
• Report Number: 8010047-2020-07514
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1