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

Model Number URF-V

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Further evaluation of the device confirmed the customer¿s reported leaks and found that they were due to perforations in the bending section cover (a-rubber).An air leak was also observed due to damage of the rotation mechanism (adjustment ring).The bending angle was lacking due to elongation of the angle wire.The adhesive of the bending section cover was chipped.The video connector was deformed and discolored.The video cable was scratched, and the video connector cover was cracked.The investigation is ongoing; therefore, the 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 that the flexible part of the subject device was leaking in two places.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.During inspection and testing, service found the light guide lens had detached.This report is being submitted for the malfunction found by service (light guide lens detached).

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.It has been over 13 years since the subject device was manufactured.Regarding air leaking through a hole of the insertion tube, based on the results of the investigation it is likely that a chemical entered from the scratch on the insertion tube and may have deteriorated the coating of the tube surface.A definitive root cause cannot be identified.Regarding the illumination lens detached, based on the results of the investigation it is likely that the lens peeled off.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of 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: 15066711
• MDR Text Key: 303830754
• Report Number: 9610595-2022-00128
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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