MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM; GASTROSCOPE

Model Number	EG-600WR V2
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A fujifilm field service engineer on site found no evidence that the brush part was still in the scope.The scope was sent to a fujifilm repair center for inspection -- there were no defects/malfunctions observed during the inspection.Although the cause of the incident is tied to the use of an un-approved brush, this incident is being considered reportable by fujifilm in an abundance of caution.
Event or Problem Description
A medline brush (not validated or recommended for use with fujifilm scopes) was used to clean a fujifilm gastroscope model eg-600wr v2.Part of this brush broke during the cleaning process.The customer is not certain if the broken brush part had gotten stuck in the scope or was flushed out of the scope.No evidence of the broken brush part was found after subsequent reprocessing cycles.The scope was used on other patients, with no reports of infection.About a week later, the customer informed fujiflim that the brush had been found; however, the customer refused to send in the brush.Fujifilm was informed that the specific medline brush model was currently being recalled by the manufacturer.

• Brand Name: FUJIFILM
• Common Device Name: GASTROSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 7714294
• Report Number: 3001722928-2018-00056
• Device Sequence Number: 16410440
• Product Code: FDS
• UDI-Device Identifier: 04547410337402
• UDI-Public: (01)04547410337402(11)170201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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-600WR V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1