MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-211D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus, after the diagnostic procedure in which the disposable biopsy forceps were used, an x-ray was performed and there was a piece of metal inside the patient's lungs.Per the reporter, the patient seemed okay, however was coughing and a bit miserable but post-procedure that's reasonably normal.The procedure was not delayed.The patient required additional treatment and is ongoing, with a repeat x-ray.An extended hospital stay was not required and the patient's overall outcome was good.The device was inspected per the instructions for use.
Event or Problem Description
Additional information received: the patient has had an mri and it was reported that what the user had seen was something from a breast surgery and not from the lung bronchoscopy.
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 information received through follow up b5 and updates to fields d10, h3 and h4.The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported event.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 the suggested event is not a product defect.The root cause of the suggested event could not be determined.The event can be detected/prevented by following the instructions for use which state: "do not coil the insertion portion with a diameter of less than 15 cm.Doing so could damage the insertion portion, and could cause the manipulation wire to become detached from the cups.If this happens, you may feel a difference when attempting to operate the instrument.For example, the slider may become loose or difficult to move.In this case, stop using the instrument immediately.If you continue to use the instrument and move the slider forward, the manipulation wire may extend from the distal end of the insertion portion, which could cause patient injury, such as bleeding or mucous membrane damages." "never use excessive force to open or close the cups.This could damage the instrument." olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• 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: 18396977
• Report Number: 9614641-2023-01993
• Device Sequence Number: 4072598
• Product Code: EOQ
• UDI-Device Identifier: 04953170389535
• UDI-Public: 04953170389535
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K950636
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: FB-211D
• Device Lot Number: 34V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2023
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2023
• 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: CYTO BRUSH; EVIS EXERA III BRONCHOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown