FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC330-A6334 60093

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-29 for FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC330-A6334 60093 manufactured by Boston Scientific Corporation.

Event Text Entries

[134351211] (b)(4). The device has been received for analysis. Upon 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.
Patient Sequence No: 1, Text Type: N, H10


[134351212] It was reported to boston scientific corporation that a fuse 1c colonoscope was used in the colon during a colonoscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the images flickers when angulating the scope. The anatomy of the patient is not visible in the center image when the image flickers. Another fuse 1c colonoscope was used to complete the procedure. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-00334
MDR Report Key8285372
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-29
Date of Report2019-02-15
Date of Event2019-01-10
Date Mfgr Received2019-01-30
Device Manufacturer Date2015-11-02
Date Added to Maude2019-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1ENDOCHOICE, INC.
Manufacturer Street11810 WILLS ROAD ,
Manufacturer CityALPHARETTA GA 30009
Manufacturer CountryUS
Manufacturer Postal Code30009
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFUSE FULL SPECTRUM ENDOSCOPY SYSTEM
Generic NameENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
Product CodePEA
Date Received2019-01-29
Returned To Mfg2019-01-15
Model NumberFSC330-A6334
Catalog Number60093
Lot Number0000700422
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-29

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