MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC ORBERA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 08/28/2020

Event Type  Injury  

Event Description

The patient had previously had a orbera gastric balloon (apollo endosurgery) for weight loss.She said the balloon was removed about a year ago.She presented to the er with a small bowel obstruction, and imaging showed a foreign body in the distal small intestine.I had to take her to surgery and resect this segment of intestine.I opened the resected small intestine segment on the back table and found a deflated, rolled up orbera balloon that was the obvious source of the problem.Fda safety report id# (b)(4).

• Brand Name: ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC
• MDR Report Key: 10477361
• MDR Text Key: 205337377
• Report Number: MW5096356
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR