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	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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, the center screen had horizontal lines.The anatomy was not visible.A second fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device code 1304 captures the reportable issue of center image lost.A fuse 1c colonoscope was received for analysis.A functional evaluation was performed and the reported issue of "line across middle screen" could not be replicated.The repair history was reviewed and nothing was found to indicate a possible service-related cause for the complaint.Since the reported issue could not be replicated, the assigned investigation conclusion code for this complaint is designated as no problem detected.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/27/2018 01:30 pm ct.The report number is being corrected from: 3005099803-2018-62283 to: 3005099803-2018-60489.
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, the center screen had horizontal lines.The anatomy was not visible.A second 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: 7897335
• Report Number: 3005099803-2018-60489
• Device Sequence Number: 18874395
• Product Code: PEA
• UDI-Device Identifier: 00816849019666
• UDI-Public: 00816849019666
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: F1C0924E1C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1