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

Model Number URF-V3

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, it was discovered that the bending tube was broken, and there was metal protruding from the bending section cover.The customer's originally reported issue of no image was not confirmed, although image artifacts were noted.The following additional findings were also noted: leak from biopsy channel, leak coming from bending section cover, dent in the connecting tube, corrosion inside the control unit, corrosion inside the connector, humidity inside the plug unit, and a defective charge-coupled device unit.The investigation is ongoing, and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that their uretero-reno videoscope device did not produce an image.Upon inspection and testing of the returned unit, it was confirmed that the bending tube was broken, and there was metal protruding through the bending section cover.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 final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 2 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that the bending tube was damaged due to strong external stress applied to the bending part, such as being pushed by excessive force while the bending part was fixed, and it protruded from the bending section cover.However, a definitive root cause could not be determined.The ifu (operation manual) describes how to handle the insertion section and bending section as follows: ¿important information ¿ please read before use warnings and cautions: warning -do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ the ifu (operation manual) describes the pre-use inspection of the bending part as follows: ¿3.3 inspection of the endoscope: inspection of the endoscope 11 inspect the bending section for protruding metallic parts.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.¿ the ifu (operation manual) describes the precautions for bending operations as follows: ¿4.1 precautions: caution: 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.¿ per the legal manufacturer, the other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.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: 16423777
• MDR Text Key: 310446617
• Report Number: 9610595-2023-03032
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: 01/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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