• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
Model Number B-50000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Internal Organ Perforation (1987)
Event Date 04/27/2016
Event Type  Injury  
Manufacturer Narrative
The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the possible outcome of stomach perforation as follows: warnings and precautions: the physiological response of the patient to the presence of the orbera system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications: possible complications of the use of the orbera system include: injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Complications of routine endoscopy include: digestive tract injury or perforation.
 
Event Description
Reported as: a patient with the orbera intragastric balloon had "gastric perforation noticed by laparoscopic exam.Patient submitted to gastric laparotomy.Patient is recovering from surgery and psychological trauma hospitalized." the balloon was removed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORBERA INTRAGASTRIC BALLOON SYSTEM
Type of Device
INTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. captial of texas hwy
bldg 1, ste. 300
austin TX 78746
Manufacturer (Section G)
ALLERGAN
global park free zone
900 global park
la aurora de heredia, costa rica, cs
CS  
Manufacturer Contact
laura leboeuf
1120 s. capital of texas hwy
bldg 1, ste 300
austin, TX 78746
5122795141
MDR Report Key5707614
MDR Text Key46855773
Report Number3006722112-2016-00151
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 05/11/2016
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 Physician
Device Expiration Date05/09/2017
Device Model NumberB-50000
Device Catalogue NumberB-50000
Device Lot Number2741863
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2016
Initial Date FDA Received06/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age30 YR
Patient Weight89
-
-