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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO CALIBRATION-FREE CAPSULE; ELECTRODE, PH, STOMACH

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GIVEN IMAGING INC. BRAVO CALIBRATION-FREE CAPSULE; ELECTRODE, PH, STOMACH Back to Search Results
Lot Number 51423F
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/11/2021
Event Type  Injury  
Event Description
During an endoscopy procedure, a physician was attempting to correctly place a bravo calibration-free capsule on a patient who was under anesthesia.There was a malfunction of the deployment mechanism of the bravo, and it had appeared to attach to the esophageal wall when it had not.When the scope was withdrawn, detection of the capsule was found in the back of the patient's mouth.Thus, the capsule had failed to properly attach to the lower third of the esophagus and had put the patient at risk for a compromised airway.We retrieved the bravo that had failed to safely attach with a snare and instead were successful in placing a new bravo capsule.There is concern because there have been quite a few times that it appeared capsule attachment was successful, when it was not.The doctor and endoscopy technicians in the room have done plenty of bravo placements, even with our new equipment, so i do not believe it to be a user error; mckesson.Fda safety report id# (b)(4).
 
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Brand Name
BRAVO CALIBRATION-FREE CAPSULE
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING INC.
MDR Report Key11285276
MDR Text Key230693809
Report NumberMW5099227
Device Sequence Number1
Product Code FFT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/02/2021
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
Device Lot Number51423F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/04/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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