MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EG-760R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 21, 2024, fujifilm corporation became aware of a complaint involving eg-760r.The customer found out the first balloon dilator would not pass during procedure (upper endoscopy), ready to dilate.The second balloon dilator passed and that is when black plastic piece noticed in patient esophagus.Black piece was then removed from the patient body and then passed the balloon dilator again and dilated the patient esophagus.There was no harm to the patient.
Additional Manufacturer Narrative
The local service center inspected the subject endoscope and found that the forceps tube had buckled and the distal end was damaged.Detailed information on the black plastic piece that fell into the patient's esophagus, including the actual piece, a photograph, and its size, was not available, and fujifilm could not determined what the black plastic piece was.Although it is difficult to identify the foreign object, since the event was confirmed after the balloon dilator insertion failure occurred, it is believed to have originated from a medical device (either an instrument used in combination during the procedure or a fragment of an endoscope damage).
Additional Manufacturer Narrative
Corrected primary unique device identifier (udi) in the section d4.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EG-760R
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 18948359
• Report Number: 3001722928-2024-00010
• Device Sequence Number: 20602627
• Product Code: FDS
• UDI-Device Identifier: 04547410358667
• UDI-Public: (01)04547410358667(11)210701
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: EG-760R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown