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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Model Number B-4800
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2017
Event Type  malfunction  
Event Description
During inflation of the orbera intragastric balloon, the balloon became dislodged.The orbera representative, was present during the procedure.The dislodged balloon was deflated and removed from the patient.The procedure continued with a new balloon.The orbera rep requested the balloon to be sent back to the manufacturer.Hospital staff contacted apollo requesting packing for return of the failed balloon.This request was not granted, and the failed balloon was disposed of per hospital biohazard protocol.
 
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Brand Name
ORBERA INTRAGASTRIC BALLOON SYSTEM
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s capital of tx hwy
bldg 1, ste 300
austin TX 78746
MDR Report Key6848061
MDR Text Key85114339
Report Number6848061
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date12/12/2018
Device Model NumberB-4800
Device Catalogue NumberB-4800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2017
Event Location Hospital
Date Report to Manufacturer08/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER, EVENT OCCURRED INTRA-OP - PATIENT WAS UND
Patient Age42 YR
Patient Weight86
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