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

Model Number	FSG250-H7641-R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
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 28g gastroscope was used during a gastroscopy procedure performed on an unknown date.According to the complainant, during the procedure, the scope was leaking air at the distal end.The complaint device was used to complete the procedure.There were no patient complications reported as a results of this event.

• 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: 7969828
• Report Number: 3005099803-2018-60883
• Device Sequence Number: 1682312
• 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
• Report Date (Section B): 10/16/2018

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: 0003000210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1