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

Model Number FUSE 1C

Device Problems Loss of or Failure to Bond (1068); Break (1069); Solder Joint Fracture (2324)

Patient Problems Abdominal Pain (1685); Tissue Damage (2104)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Based on visual inspection at the facility, endochoice has confirmed the report that the distal tip separated from the insertion tube, exposing the interior channels and cables.

Event Description

It was reported by a user that, ten minutes into the colonoscopy case, the colonoscope steering mechanism stopped working properly.When the colonoscope was withdrawn, it was noted that the bending sheath had separated from the distal tip, exposing the interior components of the endoscope.The physician noted that there was bleeding upon withdrawal and referred the patient for a ct scan.The radiological image showed evidence of mucosal inflammatory changes in the sigmoid colon.The patient was given medication for nausea and an antibiotic, and was sent home the same day.

• 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: 5247262
• MDR Text Key: 32097611
• Report Number: 3007591333-2015-00068
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FUSE 1C
• Device Catalogue Number: FSC-3300-ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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
• Patient Age: 63 YR