MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AUXILIARY WATER TUBE

Model Number	MAJ-855
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported 10 devices failed with the same issue.These events are captured in medwatches with patient identifiers as below: (b)(6).This medwatch is for the patient identifier (b)(6).The device has been returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.Facility device reprocessing information: primary cleaning of the device is performed with alkaline detergent.Disinfection process is to rotate for 5 minutes at about 90 ° c in a decompression boiling type washing machine.
Event or Problem Description
As reported for this event by the customer, during visual inspection of the device at the time of reprocessing, it was observed that rust was generated from the metal part inside the tube.The number of times of use and the period of use after delivery are unknown.There is no reported harm to any patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Device evaluation found iron, chromium, oxygen, and chlorine were detected with the energy dispersive x-ray (edx) analysis.Additionally, a hydroxide peak was found with the fourier transform infrared spectroscopy (ftir) analysis.The device history record was unable to be reviewed for this device since the lot number is unknown.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 component analysis confirmed the metal rust.It is likely that the rust was caused by the metal oxidizing due to chlorine.Additionally, chlorine can originate from water and chemicals including cleaning solutions.However, a definitive root cause of the reported issue could not be determined.Correction: the manufacturer has determined there is no potential for this issue of rust generated from the metal part inside the tube to cause or contribute to an adverse event.

• Brand Name: AUXILIARY WATER TUBE
• Common Device Name: AUXILIARY WATER TUBE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15303606
• Report Number: 9610595-2022-01368
• Device Sequence Number: 6484096
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: MAJ-855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 04/04/2023
• 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
• Patient Sex: Unknown