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 Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 c38s slim colonoscope -r was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, all images changed color during angulation.The anatomy of the patient was not visible.Another fuse c38s slim colonoscope -r was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(6).Block h6: device code 1304 captures the reportable event of center image lost.Block h10: a fuse c38s slim colonoscope - r was received for analysis.A functional evaluation was performed and found that the image flickers when the scope is angulated due to an internal wiring failure of the charged couple device (ccd) at the distal tip.The ccd was replaced to resolve the issue.The reported issue was confirmed.The cause of the reported failure is due to an internal wiring failure of the ccd at the distal tip.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, all images changed color during angulation.The anatomy of the patient was not visible.Another fuse c38s slim colonoscope -r 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: 8349383
• Report Number: 3005099803-2019-00721
• Device Sequence Number: 13900567
• Product Code: PEA
• UDI-Device Identifier: 00840253109866
• UDI-Public: 00840253109866
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/13/2019

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: 2000261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1