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

Model Number	FSC330-G7529-R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Initial reporter information was not provided.Attempts to obtain this information have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.(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
Boston scientific corporation became aware of a reported issue involving a fuse c38s slim colonoscope on (b)(6) 2018.Specific procedure details are unknown.According to the complainant, the scope had a "leak." 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
Block b3: 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.Block e1: initial reporter information was not provided.Attempts to obtain this information have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.(b)(4).Block h10: a fuse c38s slim colonoscope was received for analysis.A functional evaluation was performed and a leak was found in the bending rubber due to a damage including a tear.The bending rubber was replaced to resolve the issue.The reported issue was confirmed.The interaction between the user and device caused or contributed to the reported event.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.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: 3005099803-2018-62291 to: 3005099803-2018-61082.
Event or Problem Description
Boston scientific corporation became aware of a reported issue involving a fuse (b)(4) slim colonoscope on (b)(6) 2018.Specific procedure details are unknown.According to the complainant, the scope had a "leak." 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: 8011114
• Report Number: 3005099803-2018-61082
• Device Sequence Number: 1434045
• Product Code: FDS
• UDI-Device Identifier: 00840253114440
• UDI-Public: 00840253114440
• Combination Product (Y/N): N
• PMA/510(K) Number: K160275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: Other
• Device Model Number: FSC330-G7529-R
• Device Catalogue Number: 60093
• Device Lot Number: 2600212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1