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

Model Number URF-V2

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was cleaned, disinfected, and sterilized before it was sent in for repair.According to the customer, it is unknown when the foreign material adhered to the endoscope and it is unknown if there was a delay in the start of the pre-cleaning.The instrument suction channel was flushed with water and the instrument channel outlet was cleaned with lint-free cloths/brushes/sponges.The customer brushed the instrument channel, instrument channel port and the suction cylinder.It is unknown if the customer presoaked the endoscope in the detergent solution, however, the customer did note that the endoscope was flushed with the detergent solution.There were no abnormalities in the accessories used for reprocessing.The device was returned to olympus for evaluation and the customer's allegation was confirmed due to a pinhole on the channel tube causing water tightness to be lost.The device evaluation found foreign matter came out of the forceps channel tube and, due to corrosion on the angle mechanism, the bending section could not be controlled.In addition, the device evaluation found the following; the distal end had discoloration, the adhesive on the bending section cover had a chip, the up/down plate and the universal cord were sticky, the image guide protector had a scratch, the universal cord had a wrinkle, the light guide bundle was slipping down, due to damage on the charged coupled device unit, a foggy image occurred, due to a chip on the objective lens, a flare or ghost occurred, due to dirt on the light guide bundle, illumination was uneven and the control unit was sticky due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus, the uretero-reno videoscope had water leakages.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found; foreign matter came out of forceps channel tube and due to corrosion on the angle mechanism, the bending section could not be controlled.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

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, the observed foreign material in the instrument channel could not be identified and a definitive root cause of the issue could not be determined, however, the issue was possibly the result of observed physical damage to the device that may have caused the foreign material to remain.Additionally, a definitive root cause of the observed angulation issue could not be determined, however, due to a leak in the instrument channel, the issue was likely caused by corrosion of the parts related to the angulation operation.The event may be detected by following the instructions for use sections below: instructions, operation manual of urf-v2 chapter 3 preparation and inspection instructions, reprocessing manual of urf-v2 chapter 5 reprocessing the endoscope 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: 18138370
• MDR Text Key: 328123957
• Report Number: 9610595-2023-17240
• 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: 12/12/2023

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: 10/25/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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