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

Model Number URF-V2

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of ¿defects of bending rubber¿ was confirmed.The device evaluation found the bending section cover had a cut, the adhesive on the bending section cover was detached.The bending section cover and bending section were broken.Water tightness was lost due to a cut on the bending section cover.The distal end had a burn.The control unit, the suction cover, and the video connector had a scratch.Due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to damage, the angulation lever did not move smoothly.Due to damage on the channel tube, forceps could not be inserted smoothly, and cleaning brush could not be inserted smoothly.Due to a cut on charged coupled device cable, image noise occurred during angulation in up/down directions.Due to a cut on the charged coupled device cable, image noise occurred, and an image could not be displayed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information.

Event Description

An olympus marketing personnel reported on behalf of the customer that there were defects of bending rubber on the uretero-reno videoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: both bending section cover, and curved tube were damaged.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the damage to the bending section and tube was accumulation of stress of repeated use or external factors during handling.Breakage of the bending section wires and air leak were observed, those external factors may have caused the image signal cable of the image sensor to be abnormal.The event can be detected/prevented by following the instructions for use which state: ¿chapter 3 ¿preparation and inspection¿ section 3.3 ¿inspection of the endoscope¿ ¦inspection of the endoscope 4 inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.11 inspect the bending section for no metallic parts protruding from the bending section.12 inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.13 inspect the bending section for abnormal bending shape, or other irregularities.Chapter 3 ¿preparation and inspection¿ section 3.8 ¿inspection of the endoscopic system¿ ¦inspection of the endoscopic image 1 before inspection, wipe the objective lens with clean lint-free cloths moistened with 70% ethyl or 70% isopropyl alcohol.2 observe the palm of your hand in the wli and nbi endoscopic images.3 confirm that light is output from the endoscope¿s distal end.4 adjust the brightness level as appropriate.5 confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.6 turn the up/down angulation control lever slowly in each direction until it stops.7 turn the insertion tube rotation ring slowly in each direction until it stops.8 confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities.9 align the up indication of the insertion tube rotation ring with the up indication on the control section.¿ 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18017470
• MDR Text Key: 326682315
• Report Number: 9610595-2023-15963
• 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: 11/08/2023

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: 10/01/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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