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	10/09/2018
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 during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the center image had a "hazy flare" on the screen.Reportedly, the patient's anatomy was not visible.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
Device code 1304 captures the reportable event of center image lost.A fuse 1c colonoscope was received for analysis.A functional evaluation was performed and the reported center image lost complaint was confirmed due to moisture present in led windows.Fluid invasion likely occurred due to a damaged eto valve.The windows were replaced and the valve was repaired to resolve the issue.The reported issue was confirmed.The cause of the reported failure is due to a damaged eto valve that led to moisture present in led windows.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.
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) 2018.According to the complainant, during the procedure, the center image had a "hazy flare" on the screen.Reportedly, the patient's anatomy was not visible.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: 8032107
• Report Number: 3005099803-2018-61172
• Device Sequence Number: 11118130
• 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): 01/29/2019

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: F1C0839FUSE1C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1