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

Model Number	MH-553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the water-resistant cap metal pin is broken off on the metal adapter.The issue occurred during an unknown event.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and the device evaluation results.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.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, the root cause could not be identified.However, it is likely that physical or chemical stress was applied to the subject device during user handling, leading to the metal pin breaking off the metal adapter.User may reduce/prevent occurrence of the suggested event by handling the item in accordance with instructions for use (ifu) below.-when using this product, please follow the instruction manual (a4 size, vertical) of the endoscope on which this product is mounted or whose standard set includes this product.Note that some of the products listed in this access information sheet may not be available in some areas.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: 19354501
• Report Number: 9610595-2024-10176
• Device Sequence Number: 7466612
• Product Code: EOQ
• UDI-Device Identifier: 04953170286438
• UDI-Public: 04953170286438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963033
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: MH-553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2007
• 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