MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WATER-RESISTANT CAP; WATER RESISTANT CAP

Model Number	MAJ-1214
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned.However, an initial evaluation has not yet been conducted.Though, the investigation is underway.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that while reprocessing his olympus water-resistant cap, after autoclave sterilization, a brown rust-like substance adhered to the metal mouthpiece.There was no patient involvement during this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation, and corrections to e1 and g2.The equipment returned to olympus was not the main body of the device, but a swab from which adhered materials was collected.There was a "brown adherent material" found on the returned cotton swab.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, the brown foreign material was unable to be specified.However, probable causes for the brown foreign material include: -reprocessing was practiced in the condition that was not covered in the instruction manual, such as the temperature and period of time in the facility.-damage from autoclave sterilization while the detergent remnants remained.A final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿chapter 2 function and inspection of the accessories for reprocessing, section 2.3 water-resistant cap (maj-1214, green): inspection 1.Confirm that inside the water-resistant cap is dried and has no stain.2.Check the packing section of the water-resistant cap for cracks, scratches, and stain.3.Confirm the venting connector is not loose.¿ olympus will continue to monitor field performance for this device.

• Brand Name: WATER-RESISTANT CAP
• Common Device Name: WATER RESISTANT CAP
• 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: 17224924
• Report Number: 9610595-2023-09486
• Device Sequence Number: 20602050
• Product Code: GCJ
• UDI-Device Identifier: 04953170154492
• UDI-Public: 04953170154492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013617
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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-1214
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/09/2023
• 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