MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problems Mechanical Problem (1384); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned, the following evaluation findings were observed: the curved tube was damaged, both curved rubber and curved tube were damaged, water tightness was not maintained due to perforation of the forceps, improper insertion of the instrument into the forceps channel was observed, liquid leakage was recognized in the light guide (lg) bundle, yellowing of the light guide (lg) bundle was noted, there was noise in the image, liquid leakage was observed in the operation part, the angle locked due to corrosion of the angle mechanism, watertightness was not maintained due to tearing of the curved rubber, a curved rubber tear was noted, the curved rubber adhesive was missing, malfunction was noted on switch 1, liquid leakage was recognized on the up/down (ud) plate, the universal cord was collapsed, liquid leakage was recognized in the universal cord, and scratches were found on the video cable.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the uretero-reno videoscope had membrane damage.Upon inspection of the customer¿s returned device it was observed, the angle was locked, and the metal art of the bending tube was exposed.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root causes of the angulation lock and the metal art exposure could not be determined.The angulation may have occurred due to the rusting of the internal metal caused by the internal water invasion caused by the watertight destruction of the scope.The sticking out of the metal of the bending tube may have occurred due to a strong twisting operation to the left and right with either a fixed bending section angulation, or an irregular load such as a sudden angulation operation.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15159701
• MDR Text Key: 304963755
• Report Number: 9610595-2022-00595
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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: 07/11/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• 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