MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MH-438
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was not confirmed.The device was cleaned, disinfected, and sterilized (cds) prior to its return.According to the customer they are unaware of what the foreign material was, and there was no delay in pre-cleaning.The customer wiped and brushed the air/water nozzle with clean lint-free cloths, brushes, or sponges.The customer states they flushed the air/ water nozzle with water and air, and a detergent solution and there were no abnormalities with the accessories used for reprocessing 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 or Problem Description
The customer reported to olympus, during a diagnostic endoscopy procedure their air/ water valve had the following concern; the air/water supply button could not be operated.The device was returned for evaluation and during the evaluation it was determined that the following reportable events were identified; foreign material was on the air/ water supply button.There was no patient harm, procedural delay, or injury and the procedure was completed with the same device.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.Related patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d9.The device history record was unable to be reviewed for this device since the serial 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, the foreign material was cellulose fiber, but the root cause of the foreign material remaining was unable to be specified.The reprocessing method did not deviate from the instruction manual, and the part of the device where foreign material remained was free from physical damage.Instructions, reprocessing manual for gif-1200n chapter 6 ¿reprocessing the accessories¿ section 6.2 ¿manually cleaning the accessories¿ describes how to clean the subject device.Olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER 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: 18301413
• Report Number: 9610595-2023-19194
• Device Sequence Number: 7160231
• Product Code: FDS
• UDI-Device Identifier: 04953170071249
• UDI-Public: 04953170071249
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: MH-438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GASTROINTESTINAL VIDEOSCOPE
• Patient Sex: Unknown