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

Model Number	FSC330-G7520
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	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a fuse c38s slim colonoscope - r was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the center image flickered when the scope was angulated.The patient's anatomy was not visible on the center image when it was flickering.The procedure was completed using the complaint device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a fuse c38s slim colonoscope - r was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the center image flickered when the scope was angulated.The patient's anatomy was not visible on the center image when it was flickering.The procedure was completed using the complaint device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code 1304 was used to capture the reported event of center image lost.Block h10: a fuse c38s slim colonoscope - r was received for analysis.A functional evaluation was performed and the center image flickers when the distal tip is angulated due to an internal wiring failure of the charged couple device (ccd).Resolution would require replacing ccd.However, this unit would not be repaired and will be moved to quarantine.The reported issue was confirmed.The cause of the reported issue is due to ccd failure.Therefore, the assigned investigation conclusion code for this complaint is designated as cause traced to component failure.The repair history was reviewed and nothing was found to indicate a possible service-related cause for the complaint.

• 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: 8396374
• Report Number: 3005099803-2019-01110
• Device Sequence Number: 14162949
• Product Code: PEA
• UDI-Device Identifier: 00840253109866
• UDI-Public: 00840253109866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: FSC330-G7520
• Device Catalogue Number: 60093
• Device Lot Number: 2000212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1