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

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mechanism of the bravo, and it had appeared to attach to the esophageal wall when it had not.When the scope was withdrawn, detection of the capsule was found in the back of the patient's mouth.Thus, the capsule had failed to properly attach to the lower third of the esophagus and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).

• Brand Name: BRAVO CALIBRATION-FREE CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 11285276
• MDR Text Key: 230693809
• Report Number: MW5099227
• Device Sequence Number: 1
• Product Code: FFT
• Number of Events Reported: 1
• 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 Number: 51423F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR