Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO; ELECTRODE, PH, STOMACH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GIVEN IMAGING LTD. BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0635
Device Problems Component Missing (2306); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
Patient undergoing upper endoscopy with bravo ph capsule placement.Bravo ph capsule failed to deploy and when endoscope with bravo ph probe, but capsule was missing.Chest x-ray was ordered to rule out (r/o) aspiration of capsule.Lungs were clear.Bravo capsule was found in patient's mouth.There was no injury to patient.Procedure was aborted.Manufacturer response for gastrointestinal telemetric monitoring system, bravo capsule (per site reporter).Return defective item to manufacturer for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD.
15 hampshire street
mansfield MA 02048
MDR Report Key10850957
MDR Text Key216634241
Report Number10850957
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 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFGS-0635
Device Catalogue NumberFGS-0635
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2020
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23725 DA
-
-