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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0313
Device Problem Difficult or Delayed Separation (4044)
Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they had a capsule which failed to detach.The study showed the capsule position was in the esophagus at the end of 96 hours study.The patient experienced pain and swallowing difficulties.The pain relief was increased for the patient.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
IL  20692
Manufacturer (Section G)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
IL   20692
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key10407334
MDR Text Key202897334
Report Number9710107-2020-00355
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101361688
UDI-Public07290101361688
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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