MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BIOPSY VALVE

Model Number	MAJ-579
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.An olympus representative interviewed the facility where it was stated the following cleaning disinfecting and sterilizing process was deviated from in the following ways: the outer surface of the insertion site for flexible cystoscope products in the bedside cleaning described in the instruction manual after the examination were not wiped, the bedside cleaning did not describe the instruction manual for flexible cystoscope products after examination that involves pumping water into the channel using a suction device and the endoscope's suction valve, the user is not cleaning the adapter and suction machine to suction cleaning solution, water, and air during main cleaning and rinsing for flexible cystoscope product with suction ducts, the inside of the channel was not filled with cleaning and disinfection solution by aspirating the cleaning and disinfection solution with a syringe through the suction cleaning adapter during immersion in the endoscope at the time of main cleaning and disinfection, the t-pipe was not cleaned and disinfected as described in the instruction manual, the t-pipe has not disassembled as described in the instruction manual, if the forceps plug of the t-pipe has deteriorated due to use and was not properly replaced as described in the instruction manual, and the t-pipe was not cleaned with the brush as described in the instruction manual.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the biopsy valve was incorrectly reprocessed.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
Updated: d8, h6, h11.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided, however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause of the customer¿s deviated biopsy valve reprocessing issue could not be determined, however, the issue was likely the result of a difference in understanding between olympus' recommendations and the facility in question regarding equipment handling and reprocessing procedures.The event may be detected/prevented by following the instructions for use which states: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• 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: 20433871
• Report Number: 9610595-2024-20826
• Device Sequence Number: 12872001
• Product Code: FBN
• UDI-Device Identifier: 04953170061516
• UDI-Public: 04953170061516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-579
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown