MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX2 - LINK DESIGN - SHORT; ODE

Model Number R2002

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/20/2014

Event Type  Injury  

Event Description

The patient underwent a transoral incisionless fundoplication (tif) procedure.After the 1 o'clock position of the valve was built, there was a lot of blood.Once the blood was suctioned away, a mucosal tear was noticed.Once the surgeon finished the 5 o'clock and 7 o'clock positions, the tear was check laparoscopically which didn't reveal anything and no leaks were noted.A few sutures were placed as a precaution to close the tear and a drain was placed.The surgeon then performed a swallow study which showed no leaks, so the patient was discharged from the hospital.The patient is to follow up with the surgeon.

Manufacturer Narrative

No allegation of product malfunction and the device was disposed of per the hospital's standard operating procedure and is not available for an evaluation.

• Brand Name: ESOPHYX2 - LINK DESIGN - SHORT
• Type of Device: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th st suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th st suite 100; redmond WA 98052
• Manufacturer Contact: james brooks ; 18109 ne 76th st suite 100; redmond, WA 98052 ; 4253079200
• MDR Report Key: 3782031
• MDR Text Key: 4432298
• Report Number: 3005473391-2014-00089
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: R2002
• Device Catalogue Number: C01945-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention