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

Model Number	D-201-14304
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a colon screening the subject device fell into the patient's large intestine.It was quickly retrieved and replaced with a new tip attachment, completing the procedure.The patients health was not impacted and no additional medical interventions were required.
Additional Manufacturer Narrative
Based on the three digit lot information (43k), the subject device was manufactured in march of 2024; therefore, march 1, 2024 was chosen for the manufacture date.The device evaluation 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 (h3) and to provide an update with information received in field (h11).The device was evaluated by olympus.And no abnormalities that could lead to the reported phenomenon were presented.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, it is likely, that the reported event occurred, due to the subject product was not secured to the endoscope by medical tape.However, the root cause of the reported event could not be determined.The event can be detected/prevented, by following the instructions for use, which state: "do not use vaseline (or any lubricant that contains petroleum jelly), olive oil, alcohol or the xylocaine spray to lubricate the instrument.Doing so, could cause equipment damage or cause the instrument to fall off of the endoscope inside the patient"."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".Additional information received: it was reported, that the subject device was not secured with medical tape when attached to the endoscope and excess lubricant was wiped away sufficiently.Olympus will continue to monitor field performance for this device.

• 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: 19641215
• Report Number: 9614641-2024-01358
• Device Sequence Number: 7118908
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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
• Device Lot Number: 43K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown