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

Model Number URF-P7

Device Problem Failure to Clean Adequately (4048)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1) establishment name: (b)(6) hospital.The device was returned to olympus for evaluation, and the reported event was confirmed.There was residual liquid/foreign material found coming out of the channel tube.In addition, other evaluation findings are as follows: water tightness was lost due to a pinhole on the channel tube; the distal end was shaved; the adhesive on the bending section cover was chipped; the bending angle in the up direction did not meet the standard value due to wear of the angle wire; the light guide bundle was slipping down; the upward/downward plate was sticky, and the control unit was also sticky due to water leakage; a foggy image occurred due to damage on the objective lens; the eyepiece and the forceps elevator lever were deformed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that there was brown liquid(lubricant) coming out from the uretero-reno fibersope's forceps channel.This occurred during reprocessing for a therapeutic procedure.The intended procedure was completed with no delay; there was no report of patient harm.

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 reported foreign material/brown fluid in the instrument channel could not be identified and a definitive root cause of the issue could not be determined, however, the facility device cleaning/reprocessing was confirmed to not have been implemented in accordance with the ifu.The issue may be detected/prevented by following the instructions for use sections below: urf-p7, operation manual, chapter 3 ¿preparation and inspection¿ describes how to detect the subject event.Urf-p7, reprocessing manual, chapter 5 ¿reprocessing the endoscope¿ describes how to prevent the subject event.Reprocessing survey info: - was the device cleaned, disinfected, and sterilized before being sent to olympus? - no - was there a delay in the start of pre-cleaning? ¿ no answer - did the customer aspirate the water through the instrument/suction channel? - unknown - were there any abnormalities in the accessories used for reprocessing? - unknown - did not soak the endoscope in cleaning solution - unknown - was the air/water nozzle wiped/brushed with clean lint free cloths, brushes, or sponges? ¿ unknown - did the customer brush the instrument channel, instrument channel port, and suction cylinder? - unknown olympus will continue to monitor 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: 18422758
• MDR Text Key: 332495523
• Report Number: 9610595-2023-20599
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/30/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• 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