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

Model Number URF-V3

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the uretero-reno videoscope tested positive for one (1) colony forming unit (cfu) of peribacillus simplex on (b)(6) 2022, and tested positive for one (1) colony forming unit (cfu) of staph warnerii and sphingomonas paucimobilis on (b)(6) 2022.All channels were sampled.The issue was found during a routine culture of the scope.Sampling was taken at reprocessing, before use.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device tested positive for less than one (1) colony forming unit of unspecified micro-organisms.The obtained results are in conformance with the require target levels established by the french regulation of (b)(6)2016.The customer suspected device was returned for investigation.Upon evaluation of the returned device the following defects were found, angle rubber glue separated, and bending tube broke.The faulty parts were replaced, and the device was 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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The reprocessing steps provided by the user were reviewed where the following deviation from instructions for use (ifu) was confirmed: brushing was not performed for biopsy channel at manual cleaning.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, a deviation from ifu was confirmed therefore, reprocessing may have been conducted insufficiently.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." "manually cleaning the endoscope/brush the channel: be sure to thoroughly brush the inside of the instrument channel, the instrument channel junction, and the instrument channel port of the endoscope.Insufficient brushing may pose an infection control risk." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report has been submitted to provide additional information from the customer on hmi customer cds checklist for endoscopes.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.During pre-cleaning, the customer uses salvanios detergent, suctions water out of the instrument/suction channels and flushes out the channels.During manual cleaning, the customer used salvanios detergent with asept inmed neoclean brush to brush the operating channel, and the distal end/area around the forceps elevator.The customer manually disinfects the scopes using anioxyde 1000.The scope was stored horizontally in a cabinet and olympus is the customer¿s maintenance company.The scope was not sterilized.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.

• 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: 16504149
• MDR Text Key: 311567958
• Report Number: 9610595-2023-03951
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2023

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/14/2023; 05/12/2023
• Supplement Dates FDA Received: 04/06/2023; 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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