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

Model Number FUSE 1C

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

It was reported that, during a colonoscopy, the doctor had difficulty unlocking the angulation brake when it was in the retroflexed position.A company representative who was present unlocked the brake.There was no report of injury or other negative health consequence to the pt.Submission of this report does not, in itself, represent a conclusion that the medical device caused or contributed to an adverse event.

• 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: 4926256
• MDR Text Key: 20069025
• Report Number: 3007591333-2015-00027
• Device Sequence Number: 1
• Product Code: FDS
• 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
• Type of Report: Initial
• Report Date: 07/17/2015

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: Health Professional
• Device Model Number: FUSE 1C
• Device Catalogue Number: FSC-3300-ST
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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