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

Model Number URF-P7R

Device Problems Mechanical Problem (1384); Optical Problem (3001)

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

Event Type  malfunction  

Event Description

An olympus field service engineer reported on behalf of the customer that they have found multiple black dots from the uretero-reno fiberscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: angulation becomes locked.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

The device was returned to olympus for evaluation and the evaluation found the angulation became locked due to deterioration of angulation mechanism by rust.Additionally, due to damage to the objective lens, a foggy image occurred.The up/down angulation lever plate had a crack.Due to deformation of the up/down angulation lever plate, water tightness was lost.The control unit had corrosion due to water leakage.The forceps elevator had a crack.Due to damage on the forceps elevator, the bending section could not be fixed firmly.Due to corrosion on the angle mechanism, the bending section could not be controlled at all.The image guide bundle had a stain.The image guide bundle had significant breakages.Broken fiber and eyepiece had discoloration.The bending cover section had slack.The venting connector under the grip was deformed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation, and correction to e1, e2, and e3 as the information was inadvertently left off the initial report.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 legal manufacturer's investigation, the phenomenon likely occurred due to control section leakage during handling, which corroded the angulation mechanism.The instructions for use (ifu) identify verbiage that may help the user reduce / prevent occurrence of the suggested event: "leakage testing of the endoscope: 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.".Olympus will continue to monitor the field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 18247959
• MDR Text Key: 329499470
• Report Number: 9610595-2023-18551
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435102
• UDI-Public: 04953170435102
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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-P7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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