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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN BRAVO; ELECTRODE, PH, STOMACH
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COVIDIEN BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0312
Device Problems Loss of or Failure to Bond (1068); Activation Failure (3270)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2020
Event Type  malfunction  
Event Description
First bravo capsule did not deploy at all despite all instructions followed.The second and third ones did not attach to esophagus.There was no bravo placed on patient (3 failures available to return).For the second patient, on the same day, the bravo would not attach to esophagus.Switched to new recorder and new capsule (1 failure available to return).No harm to either patient.Manufacturer response for bravo capsule, (brand not provided) (per site reporter).I've emailed the vendor rep and she has not responded.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key11228890
MDR Text Key228633947
Report Number11228890
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2020
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 Model NumberFGS-0312
Device Catalogue NumberFGS-0312
Device Lot Number50496Q (X3) & 50870Q (X1)
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2020
Event Location Hospital
Date Report to Manufacturer01/26/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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