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	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sent the subject scope to a third-party service provider because a cleaning brush had gotten stuck in the scope.The service provider removed the brush, replaced the biopsy channel, and inspected the repaired scope to ensure that the replaced channel was free from any blockage.Despite the repair, the customer observed a blocked channel by a broken part of a cleaning brush after initial reuse of the scope.Although fujifilm cannot identify when the brush part was introduced in the scope channel, they believe it may have occurred during reprocessing of the scope by the customer prior to use.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2021, fujifilm medical systems u.S.A., inc.Was informed of an incident involving the (b)(4) gastroscope.During reprocessing of the scope, a broken piece of a cleaning brush was found in the biopsy port.There was no patient injury.The patient was tested for possible cross-contamination, and the test results came back negative.

• 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: 12016388
• Report Number: 3001722928-2021-00011
• Device Sequence Number: 4219482
• Product Code: FDS
• UDI-Device Identifier: 04547410358667
• UDI-Public: (01)04547410358667
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Y
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/17/2021
• 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: 38 YR
• Patient Weight: 75