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	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a procedure, the distal cap is visible on the endoscope screen, but when a malfunction occurs the device is not displayed.Therefore, the malfunction is easily detectable and the device is 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.Fujifilm will continue to monitor complaints for similar issues.
Event or Problem Description
On april 14, 2023, fujifilm corporation was informed of an event involving dh-28gr.It was reported that the tip of the device fell off when the scope was removed after performing a submucosal dissection.The pieces were retrieved and the procedure was completed successfully without harm or injury.There was no death reported with the event.
Additional Manufacturer Narrative
This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• 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
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 16892108
• Report Number: 3001722928-2023-00014
• Device Sequence Number: 5956020
• Product Code: FDS
• UDI-Device Identifier: 04547410331653
• UDI-Public: (01)04547410331653(17)250531(10)2206T8
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DH-28GR
• Device Catalogue Number: N/A
• Device Lot Number: 2206T8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown