MAUDE Adverse Event Report: ENDOCHOICE, INC. FUSE ENDOSCOPY SYSTEM; GASTROSCOPE AND ACCESSORIES

Model Number FUSEBOX

Device Problems No Display/Image (1183); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

On inspection of the fusebox, it was found that a failed capacitor had caused the power issue.The baseboard of the fusebox was replaced to resolve the issue.

Event Description

It was reported that the video processor would restart randomly, resulting in loss of system function during an endoscopy case.There was no patient injury or other adverse health consequence.

• Brand Name: FUSE ENDOSCOPY SYSTEM
• Type of Device: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009
• Manufacturer (Section G): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009
• Manufacturer Contact: daniel hoefer ; 11810 wills road; alpharetta, GA 30009 ; 6787084743
• MDR Report Key: 5716973
• MDR Text Key: 47201061
• Report Number: 3007591333-2016-00031
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSEBOX
• Device Catalogue Number: FSP-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 115 YR