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

Model Number FUSEBOX

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

The user reported an electrical burning smell immediately prior to a colonoscopy case, followed by the video processor unit shutting itself off.The patient had not yet been sedated at the time of this event.There was no report of injury or other negative health consequence to the patient.Submission of this report does not, in itself, represent a conclusion that the medical device caused or contributed to an adverse event.

Manufacturer Narrative

The device has shut down mechanisms in the event of over-current.It is not known whether this event represents a malfunction or if the device shut down as intended.The user installed an isolation transformer and the device was subsequently reported to be functioning normally.

• Brand Name: FUSE ENDOSCOPY SYSTEM
• Type of Device: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009
• Manufacturer Contact: 11810 wills rd; alpharetta, GA 30009 ; 6787084743
• MDR Report Key: 4902625
• MDR Text Key: 16163453
• Report Number: 3007591333-2015-00024
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1