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

Model Number	FSC-3300-ST
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although expected, the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, all images turns black and blue when angulating the scope.The anatomy of the patient was not visible on the center screen.Another fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).A fuse 1c colonoscope was received for analysis.A functional evaluation was performed and found that the image flickers when angulated due to a failed charged couple device (ccd).The reported issue was not confirmed.The image flickers when angulated.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 1c colonoscope was used during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, all images turns black and blue when angulating the scope.The anatomy of the patient was not visible on the center screen.Another fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 8069213
• Report Number: 3005099803-2018-61415
• Device Sequence Number: 1558114
• Product Code: PEA
• UDI-Device Identifier: 00816849019666
• UDI-Public: 00816849019666
• 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,Followup
• Report Date (Section B): 12/31/2018

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: FSC-3300-ST
• Device Catalogue Number: 60093
• Device Lot Number: F1C0580E1C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1