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

Model Number URF-V

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, bending angle insufficient due to the elongation of the angle wire, water tightness not maintained due to perforation of the forceps channel, burning of the tip cover, residual fluid or foreign matter coming out of the forceps channel, light guide bundle broken, curved rubber adhesive missing, scratches found on the switch box, sw2 not functioning due to sw2 failure caused, light guide connector corroded, scratches found on the light guide connector, corrosion occurred inside the light guide cover glass (cause of decrease in illumination light intensity), scratches on the light guide cover glass surface, scratches found on the operation part, scratches found on the grip, scratches on the angle lever, scratches found on the up/down plate, universal code collapsed, scratches found on the universal cord, scratches found on the video cable, scratches observed on the video cable oredome, scratches found on the video connector, video connector cracked, scratches found on the video connector case, video connector case cracked, and scratches on the up/down angle fixing lever (sp).The faulty parts will be replaced, and the device will be returned to the user facility.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.

Event Description

A user facility submitted a repair request to the olympus service center, for an uretero-reno videoscope, forceps could not be inserted and had poor bending angle.Upon inspection and testing of the returned device, foreign material was found exiting the scope forceps channel due to incorrect reprocessing.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Event Description

Customer additionally reported that the device was cleaned, disinfected, and sterilized before it was returned to olympus.There was no delay in the start of precleaning.The air/water nozzle was not flushed with water and air.No abnormalities in the accessories used in reprocessing.The nozzle was not wiped/brushed with a clean lint-free cloth/brush/sponge.The instrument channel was brushed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to b5 and h4.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 root cause of the foreign material was insufficient cleaning.Identification of the material could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16694335
• MDR Text Key: 313205213
• Report Number: 3002808148-2023-03428
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• 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: 05/11/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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