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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 Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 05/30/2019
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 attach.It was in the wrong passage when it was rechecked, but the capsule was removed afterwards.There was no harm to the patient or user, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule.Another capsule was used to resolve the issue.
 
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 attach.It was in the wrong passage when it was rechecked, but the capsule was removed afterwards.There was no harm to the patient or user, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.Another capsule was used to resolve the issue.
 
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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
Manufacturer (Section G)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key8730865
MDR Text Key149077982
Report Number9710107-2019-00281
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101361688
UDI-Public07290101361688
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/16/2019
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number41935Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Date Manufacturer Received06/03/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age4 YR
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