MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FUSE; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	FSG250-H7641
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fuse g28 gastroscope - r was received for analysis.A functional analysis was performed and found moisture in the forward lens.The scope was aerated and the lens was replaced to resolve the issue.The reported issue of center image lost was confirmed.The issue was due to the moisture in the forward lens.The moisture interfered with the image circuits.After aerating the scope and drying out the circuits, replacing the lens and resealing the scope corrected the issue.Therefore, the assigned investigation conclusion code for this complaint is designated as cause traced to component failure.
Event or Problem Description
It was reported to boston scientific corporation that a fuse g28 gastroscope - r was used during a gastroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the center image was blurry.The patient's anatomy was not visible on the center image when it was blurry.Another fuse g28 gastroscope - r was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: FUSE
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8306753
• Report Number: 3005099803-2019-00479
• Device Sequence Number: 13466106
• Product Code: FDS
• UDI-Device Identifier: 00840253109811
• UDI-Public: 00840253109811
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: FSG250-H7641
• Device Catalogue Number: 60094
• Device Lot Number: 2900227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1