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

Model Number	FSC-3300-SL-R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
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 manufacturer became aware of the event.(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 used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that the exterior at the tip of the scope was torn.This caused fluids to leak into the scope, resulting in damage to the front camera.There were no patient complications reported as a results of this event.The procedure was completed with another scope.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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 manufacturer became aware of the event.Device code 1354 captures the reportable issue of leak at scope tip during a procedure.A fuse 1c colonoscope was received for analysis.A functional evaluation was performed and a leak was found in the air/water channel.The channel was replaced to resolve the issue.Additionally, the charged couple device (ccd) was experiencing photo plated damage and was replaced to resolve the issue.Since the image issue is confirmed due to leak in the air/water channel and ccd damage, 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 used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that the exterior at the tip of the scope was torn.This caused fluids to leak into the scope, resulting in damage to the front camera.There were no patient complications reported as a results of this event.The procedure was completed with another scope.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8053093
• Report Number: 3005099803-2018-61220
• Device Sequence Number: 16596059
• Product Code: PEA
• UDI-Device Identifier: 00840253114495
• UDI-Public: 00840253114495
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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-SL-R
• Device Catalogue Number: 60093
• Device Lot Number: 0001000378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1