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

Model Number FUSE 1C

Device Problems Device Issue (2379); Dent in Material (2526)

Patient Problems Laceration(s) (1946); Patient Problem/Medical Problem (2688)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Based on inspection of the device at the service center, the issue was attributed to a dented or punctured insertion tube.The device was repaired.

Event Description

It was reported that angulation of the colonoscope was too tight.Bleeding resulted when retro-flexing of the scope at the rectum was being reversed.Two clips were used to stop the bleeding.There was no further patient injury or other adverse health consequence.

• Brand Name: FUSE ENDOSCOPY SYSTEM
• Type of Device: COLONOSCOPE 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: 6021039
• MDR Text Key: 57149853
• Report Number: 3007591333-2016-00051
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSE 1C
• Device Catalogue Number: FSC330-F7523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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 Outcome(s): Required Intervention