MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM EG-760R GASTROSCOPE; GASTROSCOPE AND ACCESSORIES

Model Number	EG-760R
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the device investigation results, a borescope was used to inspect the channel of the scope and there were no damages in the channel.However, there were scratches on the distal cap which appears to be damage from the customer.The scratches on the distal cap were determined to be unrelated to the presence of foreign matter.Fujifilm does not believe that the foreign object came from the endoscope or forceps.However, fujifilm was unable to determine the cause for the presence of the foreign object.If any additional relevant information becomes available, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2021, fujifilm corporation was informed of an incident involving the eg-760r gastroscope.During the beginning of an egd procedure, the doctor pushed biopsy forceps through a channel and felt resistance.As soon as the doctor was able to get through, a piece of plastic came out.The foreign object appears to be a piece of plastic, however it was not confirmed.It was confirmed that the doctor proceeded to use the scope and was able to complete to procedure.There was no injury or adverse event that occurred to the patient.After completion the scope was reprocessed and removed from service.There was no patient impact, injury or death associated with this event.This report is being submitted in abundance of caution.

• Brand Name: FUJIFILM EG-760R GASTROSCOPE
• 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: 12312798
• Report Number: 3001722928-2021-00020
• Device Sequence Number: 4062734
• Product Code: FDS
• UDI-Device Identifier: 14547410358664
• UDI-Public: (01)14547410358664(11)200401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: EG-760R
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Patient Age: 63 YR
• Patient Weight: 97