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

Model Number 1C

Device Problem Insufficient Information (3190)

Patient Problem Excessive Tear Production (2235)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

Additional information could not be obtained, as the incident that was just reported had occurred 4 months ago.

Event Description

Patient underwent a colonoscopy, in which a small, transverse colonic polyp was removed by cold snare polypectomy from the distal transverse colon.That night the patient developed lower abdominal pain and was presented to the emergency room.A ct scan showed evidence of a splenic laceration.She was admitted into the icu and observed.There was an attempt to reverse the xarelto prescription the patient was taking, but with no true reversal agent.The patient then underwent blood transfusions and after 3 days was taken to the operating room for a splenectomy due to persistent pain.She remained in the hospital for an additional week, from which there were no reported problems after her hospitalization.

• Brand Name: FUSE COLONOSCOPY SYSTEM
• Type of Device: COLONOSCOPY AND ACCESSORIES
• Manufacturer (Section D): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009
• Manufacturer Contact: daniel hoefer ; 11810 wills rd; alpharetta, GA 30009 ; 6787084743
• MDR Report Key: 5305527
• MDR Text Key: 33788114
• Report Number: 3007591333-2015-00079
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1C
• Device Catalogue Number: FSC-3300-ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR