MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM HOOD MODEL DH-30CR; GASTROSCOPE AND ACCESSORIES

Model Number	DH-30CR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving (b)(4).This report addresses the first of two cases that occurred on the same day at the same facility.It was reported that during a colonoscopy, the hood separated at the junction of its two sections while attached to the endoscope and fell into the gastrointestinal tract.The piece was retrieved and the procedure was completed successfully without harm or injury.There was no death reported with the event.

• Brand Name: FUJIFILM HOOD MODEL DH-30CR
• 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: 16930277
• Report Number: 1000513161-2023-00020
• Device Sequence Number: 7008356
• Product Code: FDS
• UDI-Device Identifier: 04547410331677
• UDI-Public: (01)04547410331677(17)241130(10)2112T2
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DH-30CR
• Device Catalogue Number: N/A
• Device Lot Number: 2112T2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Device Age: 15 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown