MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM HOOD MODEL DH-28GR; GASTROSCOPE AND ACCESSORIES

Model Number	DH-28GR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a procedure, the distal cap was visible on the endoscope screen, but when a malfunction occurs the device was not displayed.Therefore, the malfunction was easily detectable and the device was easily retrievable.The root cause is determined to be a result of product variance.Therefore, the acceptance criteria for product inspection were reviewed and updated to strengthen quality control.However, fujifilm determined that the effect was not sufficient, so the structure of this product was changed.Improvements were not applied to this lot.Fujifilm will continue to monitor complaints for similar issues.
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving with dh-28gr.It was reported that the hood separated and fell into the gastrointestinal tract.The piece was retrieved and a new hood was attached to the endoscope, and the procedure was completed successfully without harm or injury.

• Brand Name: FUJIFILM HOOD MODEL DH-28GR
• Common Device Name: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18046101
• Report Number: 1000513161-2023-00073
• Device Sequence Number: 7500323
• Product Code: FDS
• UDI-Device Identifier: 04547410331653
• UDI-Public: (01)04547410331653(17)241231(10)2201T4
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

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 Expiration Date: 12/31/2024
• Device Model Number: DH-28GR
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 2201T4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2023
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown