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

Model Number URF-V3

Device Problem Peeled/Delaminated (1454)

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 allegations was confirmed.The evaluation found the following: due to a pinhole on connecting tube, water tightness is lost; connecting tube has coating peeling.(maximum width 4mm or more); due to wear of angle wire, bending angle in upwards direction does not meet the standard value; grip has a scratch; angulation lever has a scratch; insertion tube rotation ring has a scratch; universal cord has coating peeling; video cable has a scratch; video cable has coating peeling; video connector case has a scratch; and due to wear of angle wire, bending angle in upwards direction does not meet the standard value.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the uretero-reno videoscope, had air leak from the image guide pipe.The event was found during an unknown event.The procedure was unknown.There were no reports of patient or user harm associated with this event.The device was returned to olympus for evaluation, and the evaluation found that the image guide tube coat peeling.This report 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 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, it is likely that the event occurred due to stress of repeated use, external factors, or handling.The event can be prevented by following the instructions for use (ifu) which state: "chapter 3 preparation and inspection 3.3 preparation and inspection of the endoscope.Inspection of the endoscope 2 inspect the control section for any irregularities such as excessive scratching, deformation, and loose parts.3 inspect the boot and the insertion section near the boot for any irregularities such as bends, twists, tears, and cracks.4 inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.9 inspect the adhesives attaching the bending section cover to the insertion section for any irregularities such as deterioration, pitting, cracking, and peeling.Also, inspect the bending section cover for any irregularities such as bulges, swelling, scratches, and holes." 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: 18030425
• MDR Text Key: 326860896
• Report Number: 9610595-2023-16083
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• 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: 12/14/2023

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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