MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FUSE; ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT

Model Number	FSC-3300-ST
Medical Device Problem Codes	Image Display Error/Artifact (1304); Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fuse scope was received for analysis.A visual analysis was performed and fluid damage was noted in the electrical connector.The reported issue was confirmed.Fluid invasion caused corrosion/buildup in the electrical connector which contributed to a short in the imaging circuit leading to the reported image issue.Fluid entered the connector as a result of improper handling of the scope.Based on a thorough review of the reported complaint, the most probable cause for this complaint is unintended use error caused or contributed to event.The repair history was reviewed and nothing was found to indicate a possible service-related cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a fuse 1c colonoscope was during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the center screen went in and out.Reportedly, the images were intermittent all throughout the procedure.The patient's anatomy was not visible on the center image when these issues occurred.The procedure was completed with another fuse 1c colonoscope.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: FUSE
• Common Device Name: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9289923
• Report Number: 3005099803-2019-05332
• Device Sequence Number: 1865167
• Product Code: PEA
• UDI-Device Identifier: 00816849019666
• UDI-Public: 00816849019666
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: FSC-3300-ST
• Device Catalogue Number: 60093
• Device Lot Number: F1C0710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1