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

Model Number	D-201-11304
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	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer that the disposable distal attachment came off the gastroscope in the middle of an unknown standard procedure.The ear nose throat (ent) staff were required to assist in the retrieval of the cap to prevent it from passing into the trachea, and it was retrieved successfully.There was no mis-diagnosis as a result of the issue.
Additional Manufacturer Narrative
The device has not been received for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 was determined that the distal cap detached from the scope because the scope was not compatible with the specific device (model number: d-201-11304).The event can be detected/prevented by following the instructions for use (ifu) which state: ¿use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, the instrument may fall off of the endoscope inside the patient and may cause malfunction or equipment damage.¿ per the ifu, ¿gif-xq240 is not compatible with d-201-11304.¿ this supplemental report includes information added to b5.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the incident occurred during an unspecified diagnostic gastroscopy procedure.Although there was procedural delay, the duration of the delay was unspecified.However, it was confirmed that the issue did not have any impact on the patient.

• 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: 18424897
• Report Number: 9614641-2024-00001
• Device Sequence Number: 15476111
• Product Code: FDS
• UDI-Device Identifier: 04953170278273
• UDI-Public: 04953170278273
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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-201-11304
• Was Device Available for Evaluation?: No
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNKNOWN GASTROSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown