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

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Cramp(s) (2193); Complaint, Ill-Defined (2331); Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 07/12/2017

Event Type  Injury  

Event Description

Orbera gastric bubble placed 9 days previously and decision to remove device secondary to fullness, nausea, cramping.Made npo for 7 hours prior to sedation.An attempted removal 1.5l of stomach content expelled explosively (2-3 days of ingested material).Device removal aborted due to concern about aspiration.Hospitalized overnight with low pulse ox and discharged next day.

• Brand Name: ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 6717789
• MDR Text Key: 80314193
• Report Number: MW5071018
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 95