MAUDE Adverse Event Report: ORBERA; ORBERA GASTIC BALLOON

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Perforation (2001); Obstruction/Occlusion (2422)

Event Date 09/27/2017

Event Type  malfunction  

Event Description

Pt experienced a gastric outlet obstruction and microperforation of the stomach as a result of the suspected orbera intragastric balloon she had placed in (b)(6).

• Brand Name: ORBERA
• Type of Device: ORBERA GASTIC BALLOON
• MDR Report Key: 7095221
• MDR Text Key: 94307403
• Report Number: 7095221
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2017
• Distributor Facility Aware Date: 11/22/2017
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR