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

Model Number URF-V2

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found to have a broken bending rubber.Metal was observed to be sticking out.According to the reporter, the issue occurred during a reprocessing.The reporter stated that prior to the event reported, the device was used on a cystoscopy, stone basket extraction, right ureteroscopy laser lithotripsy procedure and suspected that the malfunction may have been present immediately prior to reprocessing the device.The device however was inspected prior to use.The intended procedure was completed using the same device.There was no patient harm or impact reported.No user injury reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.Device evaluation found a broken bending tube.The cause of breakage of the bending tube was not able to be identified.Based on device evaluation, it was assumed that a way of operation by the user resulted in application of excessive force to the bending section caused the reported failure.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.Olympus will continue to monitor complaints for this device.

• 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
• MDR Report Key: 10573496
• MDR Text Key: 208135716
• Report Number: 8010047-2020-06775
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR