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

Model Number LS-FSC330-C6337

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2018

Event Type  malfunction  

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 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 leds stopped working.There was loss of center image.Another fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.

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 found that the middle led would turn off when flexing the scope, indicating an electrical fault in the imaging circuit.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.It was not known what caused the internal wiring failure of the ccd.Therefore, the assigned investigation conclusion code for this complaint is cause traced to component failure.The repair history was reviewed and nothing was found to indicate a possible service-related cause for the complaint.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 02:45 pm ct.The report number is being corrected from: 3005099803-2018-62288to: 3005099803-2018-61171.

Event 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 leds stopped working.There was loss of center image.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 FULL SPECTRUM ENDOSCOPY SYSTEM
• Type of Device: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8030639
• MDR Text Key: 125911711
• Report Number: 3005099803-2018-61171
• Device Sequence Number: 1
• Product Code: PEA
• Combination Product (y/n): N
• PMA/PMN Number: K160275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS-FSC330-C6337
• Device Catalogue Number: 60093
• Device Lot Number: 1000317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1