MAUDE Adverse Event Report: GIVEN IMAGING INC/ COVIDIEN/MEDTRONIC INC BRAVO CF CAPSULE; ELECTRODE, PH, STOMACH

Lot Number 49384F

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Bravo capsule device was deployed during upper gi endoscopy.It did not adhere to the patient's esophagus.The physician was able to remove the capsule with a snare.No patient harm was noted.Procedure was completed without any other complications.Fda safety report id# (b)(4).

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC/ COVIDIEN/MEDTRONIC INC
• MDR Report Key: 10301452
• MDR Text Key: 199884279
• Report Number: MW5095616
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Lot Number: 49384F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 64 YR