Bravo FGS-0313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,103 adverse event reports that list this exact device (DI 07290101361688), received between Apr 4, 2017 and Oct 6, 2022 — classified as 91 injuries, 1,012 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (519 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,103 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, APPROXIMATELY 3 HOURS POST PROCEDURE, THE CAPSULE HAD NO DATA RECEPTION. A REPEAT PROCEDURE WAS PLANNED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554474 ↗
• MalfunctionOct 4, 2022Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: Airway Obstruction

  MAUDE report 15540330 ↗
• InjurySep 14, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS. THE CAPSULE WAS LOCATED IN THE ESOPHAGUS AND RETRIEVED USING BIOPSY FORCEPS. THEY PLACED ANOTHER CAPSULE ON THE SAME PROCEDURE. THE PHYSICIAN VERIFIED THE CAPSULE PLACEMENT ENDOSCOPICALLY, THE DEPLOYMENT DEVICE INSERTED WITH THE CAPSULE WAS FACING THE TONGUE AND THE DEPLOYMENT DEVICE WAS INSERTED WHILE THE ENTIRE DEVICE INCLUDING THE HANDLE WAS MAINTAINED IN THE HORIZONTAL PLANE. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Airway Obstruction

  MAUDE report 12467629 ↗
• InjuryAug 12, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH AND FELL INTO THE ESOPHAGUS. THE CAPSULE WAS RETRIEVED BUT THE WITH AN UNKNOWN DEVICE. THEY CALIBRATED A NEW CAPSULE AND IT DEPLOYED SUCCESSFULLY. THE PATIENT WAS NOW STABLE.

  Patient problems: Airway Obstruction

  MAUDE report 12315355 ↗
• MalfunctionAug 5, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THEY PLACED ANOTHER CAPSULE AND IT ATTACHED SUCCESSFULLY. THERE WAS NO PATIENT AND USER HARM, AND NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283155 ↗
• InjuryJul 1, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO DEPLOY IN THE ESOPHAGUS AND WAS RETRIEVED IN THE STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 12105247 ↗
• InjuryJun 9, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. A SECOND ATTEMPT WAS DONE ON THE SAME EVENT BUT IT ALSO FAILED TO ATTACH. IT DROPPED ON THE BACK OF THE THROAT AND A FORCEPS DEVICE WAS USED TO RETRIEVE IT. NO LUBRICANT WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Airway Obstruction

  MAUDE report 11968618 ↗
• MalfunctionJun 9, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENTS ESOPHAGUS AND STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. A SECOND ATTEMPT WAS DONE ON THE SAME EVENT BUT IT ALSO FAILED TO ATTACH. IT DROPPED ON THE BACK OF THE THROAT AND A FORCEPS DEVICE WAS USED TO RETRIEVE IT. NO LUBRICANT WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968613 ↗
• InjuryJun 9, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD 2 CAPSULES WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND DROPPED IN THE PATIENT¿S BACK OF THE THROAT. THE CAPSULES WERE RETRIEVED USING A FORCEPS DEVICE. NO LUBRICANT WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Airway Obstruction

  MAUDE report 11968610 ↗
• InjuryMay 13, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD 3 CAPSULES THAT FAILED TO ATTACH ON THE SAME PATIENT. 2 CAPSULES FAILED TO ATTACH AND THE 3RD CAPSULE FELL IN THE STOMACH AND RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11823097 ↗
• MalfunctionMay 13, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD THREE CAPSULES THAT FAILED TO ATTACH ON THE SAME PATIENT. TWO CAPSULES FAILED TO ATTACH AND THE THIRD CAPSULE FELL IN THE STOMACH AND RETRIEVED. THERE WAS NO USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819349 ↗
• MalfunctionApr 27, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACHED. NEW CAPSULE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: Airway Obstruction

  MAUDE report 11733651 ↗
• InjuryApr 20, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THE CAPSULE WAS FOUND IN THE POSTERIOR PHARYNX OF THE PATIENT AND IT WAS FREE FLOATING. MCGILL FORCEPS WAS USED TO REMOVE THE CAPSULE. THEY RECALIBRATE A NEW UNIT AND PATIENT WAS PUT BACK UNDER ANESTHESIA AND THE DEVICE WAS SUCCESSFULLY PLACED. A REPEAT PROCEDURE WAS PERFORMED AT THE SAME TIME.

  Patient problems: Airway Obstruction

  MAUDE report 11694095 ↗
• MalfunctionApr 5, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THE DEVICE DID NOT DEPLOY FROM THE DELIVERY DEVICE. THERE WAS NO HARM TO THE PATIENT AND THE USER, NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Airway Obstruction

  MAUDE report 11616845 ↗
• MalfunctionMar 22, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND THE USER, NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Airway Obstruction

  MAUDE report 11541493 ↗
• MalfunctionMar 8, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT, AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE, AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE THAT SHOWED THE ESOPHAGUS TO BE NORMAL. THE PHYSICIAN VERIFIED THE CAPSULE PLACEMENT ENDOSCOPICALLY. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE, AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435155 ↗
• MalfunctionFeb 16, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE REPEAT PROCEDURE WAS DONE ON THE SAME PROCEDURE. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. THE PHYSICIAN VERIFIED THE CAPSULE PLACEMENT ENDOSCOPICALLY. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331414 ↗
• InjuryFeb 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FIRST CAPSULE FAILED TO ATTACH. IT WAS FOUND IN ORAL PHARYNX AND WAS RETRIEVED WITH FINGER. THE PATIENT HAD A MONITORED ANESTHESIA CARE - PROPOFOL DURING THE INITIAL PROCEDURE. THE SECOND PROCEDURE IMMEDIATELY TOOK PLACE AFTER THE FIRST AND AN ADDITIONAL ANESTHESIA WAS GIVEN TO THE PATIENT. THE SECOND CAPSULE FAILED TO DETACH. THEY PULLED OUT THE CATHETER PAST THE PATIENT¿S MOUTH AND THE CAPSULE FELL RIGHT OUT OF THE DEVICE. THERE WAS NO USER HARM.

  Patient problems: Foreign Body In Patient; Oversedation

  MAUDE report 11321775 ↗
• MalfunctionFeb 12, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321203 ↗
• InjuryFeb 11, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THE FIRST CAPSULE FAILED TO ATTACH. IT WAS FOUND IN ORAL PHARYNX AND WAS RETRIEVED WITH FINGER. THE PATIENT HAD A MONITORED ANESTHESIA CARE - PROPOFOL DURING THE INITIAL PROCEDURE. THE SECOND PROCEDURE IMMEDIATELY TOOK PLACE AFTER THE FIRST AND AN ADDITIONAL ANESTHESIA WAS GIVEN TO THE PATIENT. THE SECOND CAPSULE FAILED TO DETACH. THEY PULLED OUT THE CATHETER PAST THE PATIENT¿S MOUTH AND THE CAPSULE FELL RIGHT OUT OF THE DEVICE. THERE WAS NO USER HARM.

  Patient problems: Foreign Body In Patient; Oversedation

  MAUDE report 11313665 ↗
• MalfunctionFeb 5, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE, AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE THAT SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE, AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284563 ↗
• MalfunctionJan 20, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THE FIRST CAPSULE FAILED TO ATTACH. USED A SECOND CAPSULE BUT THE HANDLE BROKE PRIOR TO TRYING TO PUT THE CAPSULE ON THE PATIENT'S ESOPHAGUS. A THIRD CAPSULE WAS USED AND IT WAS SUCCESSFUL. THERE WAS NO HARM TO THE PATIENT AND THE USER, NO INTERVENTION WAS REQUIRED. AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11203443 ↗
• MalfunctionJan 19, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195097 ↗
• InjuryJan 19, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE. THE PROCEDURE WAS REPEATED ON THE SAME DAY AFTER AN HOUR, HOWEVER A REPEAT SEDATION WAS ALSO PERFORMED ON THE PATIENT.

  Patient problems: Oversedation

  MAUDE report 11195042 ↗
• MalfunctionJan 11, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND THE USER. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE, AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE THAT SHOWED THE ESOPHAGUS TO BE NORMAL. THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146604 ↗