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

Model Number	FSC330-G7520
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fuse c38s slim colonscope - r was received for analysis.A visual analysis was performed and moisture was found in f2 led window most likely due to glue deterioration around the seal.The scope was aerated and the window was replaced to resolve the issue.The "water in front lens" issue was confirmed due to glue deterioration around the seal.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 c38s slim colonoscope - r was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, water was noted in the front lens.The procedure was completed using the complaint device.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: 8387682
• Report Number: 3005099803-2019-01037
• Device Sequence Number: 420562
• Product Code: PEA
• UDI-Device Identifier: 00840253109866
• UDI-Public: 00840253109866
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 2000269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1