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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOCHOICE INC. FUSE ENDOSCOPY SYSTEM; GASTROSCOPE AND ACCESSORIES
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ENDOCHOICE INC. FUSE ENDOSCOPY SYSTEM; GASTROSCOPE AND ACCESSORIES Back to Search Results
Model Number FUSEBOX
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2015
Event Type  malfunction  
Event Description
It was reported that, during an endoscopy, the video processor unit shut down, resulting loss of all display capability.There was no report of injury or other negative health consequence to any pt.
 
Manufacturer Narrative
The investigation at the endochoice service center determined that a base board, a circuit board, and a hard drive in the video processor had failed.
 
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Brand Name
FUSE ENDOSCOPY SYSTEM
Type of Device
GASTROSCOPE AND ACCESSORIES
Manufacturer (Section D)
ENDOCHOICE INC.
11810 wills rd
alpharetta GA 30009
Manufacturer Contact
11810 wills rd
alpharetta, GA 30009
6787084743
MDR Report Key4935719
MDR Text Key6051891
Report Number3007591333-2015-00028
Device Sequence Number1
Product Code FDF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Remedial Action Repair
Type of Report Initial
Report Date 07/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFUSEBOX
Device Catalogue NumberFSF-100
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/23/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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