MAUDE Adverse Event Report: ENDOCHOICE, INC. FUSE 1G; GASTROSCOPE AND ACCESSORIES

Model Number FSG-2500-ST

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2017

Event Type  malfunction  

Manufacturer Narrative

The gastroscope was evaluated at the authorized repair facility.It was determined that the ccd camera assembly had malfunctioned, and it was replaced.The device was returned to the user facility.

Event Description

It was reported that all images were lost during a gastroscopy.The physician used a different enoscope to complete the case.There were no reported adverse health consequences to the patient.

• Brand Name: FUSE 1G
• Type of Device: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer (Section G): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer Contact: daniel hoefer ; 11810 wills road; alpharetta, GA 30009-2081 ; 6787084743
• MDR Report Key: 6887161
• MDR Text Key: 87375709
• Report Number: 3007591333-2017-00046
• 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: 09/22/2017

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
• Device Operator: Physician
• Device Model Number: FSG-2500-ST
• Device Catalogue Number: FSG-2500-ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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