MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-14304
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic endoscopic submucosal dissection, a crack appeared midway on the subject device and eventually broke.The fallen parts were collected.The procedure was then completed with a similar device without reports of patient harm.The device was inspected prior to use without any issues noted.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields (b5, d9, h3, and h11- additional information received) and to provide a correction to field (g2) with information inadvertently left out.The device was evaluated by olympus, and the cap was broken.Additional information received: it was reported that no lubricant or chemical agent was applied to the subject device.Additionally, medical tape was not used tp secure the subject device to the endoscope.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and past investigation results, it is likely that the reported event occurred due to the following mechanisms.1.) due to oils in the patient¿s body, the complaint product swelled, and their mechanical properties deteriorated.2.) when the endoscope was inserted into the body, stress was generated that pushed the product into the endoscope.3.) the product broke due to the stress above.Furthermore, it is inferred that the product fell off inside the body because it was broken and because it was not firmly secured to the endoscope by medical tape.However, a specific root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "do not bend, pull or compress the product excessively, as this may result in damage to the instrument or a decrease in its functionality." "be sure to wipe away any excess lubricant before mounting the instrument, and secure the instrument firmly using medical tape with sufficient elasticity.If the instrument is not firmly secured, it could come off inside the body cavity during use and cause patient injury, such as mucous membrane damage.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the subject device fell into the transverse colon and was retrieved using grasping forceps.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20556042
• Report Number: 9614641-2024-02045
• Device Sequence Number: 8996083
• Product Code: FDS
• UDI-Device Identifier: 04953170453892
• UDI-Public: 04953170453892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-201-14304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CF-XZ1200I/UNKNOWN SERIAL NUMBER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian