MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FUSE; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	FSG250-H7641-R
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(b)(4).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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a fuse g28 gastroscope - r was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the image from the colonoscope was lost during angulation.There was a green image on both monitors.There were no patient complications reported as a result of this event.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
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.Device code 1304 captures the reportable issue of center image lost.A fuse g28 gastroscope: r was received for analysis.A functional evaluation was performed and found no image due to heavy corrosion in the electrical connector.The connector was replaced to resolve the issue.The reported issue was confirmed.Fluid invasion in the electrical connector could contribute to a short in the imaging circuit and lead to the reported image issue.Fluid can enter the connector as a result of improper handling of the scope.Therefore, the assigned investigation conclusion code for this complaint is designated as unintended use error caused or contributed to event.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 g28 gastroscope - r was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the image from the colonoscope was lost during angulation.There was a green image on both monitors.There were no patient complications reported as a result of this event.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: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8179167
• Report Number: 3005099803-2018-62039
• Device Sequence Number: 1960094
• Product Code: FDS
• UDI-Device Identifier: 00840253114457
• UDI-Public: 00840253114457
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/20/2019

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: FSG250-H7641-R
• Device Catalogue Number: 60094
• Device Lot Number: 0002900286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1