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

Model Number	FSC330-G7520
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the device was received at the repair center.(b)(6).(b)(4).A fuse scope was received for analysis.A functional evaluation was performed and it was found out that static is present in the image when the scope is angulated, indicative of a charge-coupled device (ccd) internal wiring failure.Since the image issue is confirmed due to internal wiring failure, 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 c38s slim colonoscope - r was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the scope whited out.The anatomy of the patient was not visible when the scope whited out.The procedure was completed with another fuse c38s slim colonoscope- r.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: 8392248
• Report Number: 3005099803-2019-01038
• Device Sequence Number: 11251578
• Product Code: PEA
• UDI-Device Identifier: 00840253109866
• UDI-Public: 00840253109866
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/05/2019

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: 2000252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1