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

Model Number URF-V3R

Device Problems Corroded (1131); Mechanical Problem (1384)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

The field service engineer (fse) reported to olympus, that the uretero-reno videoscope angulation lock does not work.And air water leaks detected from tip of the scope.The issue was found during receipt inspection at the repair center.Inspection and testing of the returned device found corrosion on the mobile part of the control lever and bending section was immobile.There were no reports of patient harm.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 customer's allegation was not confirmed.The device evaluation found, up and down bending angle failed; due to damage on channel tube.The water tightness is lost; due to corrosion.Switch buttons 1 and 3 does not work.Adhesive on bending rubber is detached.Due to corrosion on the angle mechanism; the bending section cannot be controlled at all.Due to a dent on channel tube; the channel cleaning brush cannot inserted smoothly.Due to a dent on channel tube; the forceps cannot be inserted smoothly.Due to damage on forceps elevator; the bending section cannot be fixed firmly.Image guide protector has a cut.Control unit has corrosion; due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years that the subject device was manufactured.The dhr (manufacturing history) was reviewed to confirm that the equipment was shipped to specifications.Based on the results of investigation, the likely cause is determined to be due to due to water entering the operation unit from the leakage point of the forceps channel while the user was handling it.It is possible that physical stress applied to the forceps channel during handling by the user may have damaged the forceps channel and made it impossible to maintain watertightness, but we have not been able to identify the cause.A definitive root cause could not be identified.The issue is addressed in the instructions for use (ifu): instruction manual urf-v3/v3r reprocessing manual chapter 5 reprocessing the endoscope 5.4 leakage testing of the endoscope.If handled according to the ifu below, the user may be able to reduce/prevent the occurrence of this event.Instruction manual urf-v3/v3r reprocessing manual chapter 1 general policy 1.4 precautions :perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Instruction manual urf-v3/v3r operation manual chapter 4 operation 4.3 using endotherapy accessories:when inserting or withdrawing an endotherapy accessory, confirm that its distal end is closed or completely retracted into the sheath.Insert or withdraw the endotherapy accessory slowly and straight into or from the forceps port of the forceps/ irrigation plug.Otherwise, the biopsy valve may be damaged and pieces of it could fall off.Olympus will continue to monitor the field performance of the 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: 16958861
• MDR Text Key: 315540320
• Report Number: 9610595-2023-07683
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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-V3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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