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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-0312
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2017
Event Type  malfunction  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, a bravo capsule failed to attach during the procedure.There was no harm to the patient or user and a repeat procedure was necessary due to the alleged device malfunction.The equipment and capsule is expected to be returned for evaluation.
 
Manufacturer Narrative
Device evaluation: one bravo ph capsule delivery device and one capsule were received for investigation.The capsule was not attached to the delivery device.Visual inspection did not reveal any damage, and appears to have functioned within specification.Functional testing could not be performed because this is a single use device and once the capsule is delivered, it cannot be functionally tested.Investigation conclusion for the failure to attach could not be reliably determined.A review of the device history record was performed and indicates that the product was released meeting finished product specifications.We were unable to confirm the customer¿s report.If information is provided in the future, a supplemental report will be issued.
 
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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
15 hampshire street
mansfield, MA 02048
7632104064
MDR Report Key6876759
MDR Text Key86641515
Report Number9710107-2017-05497
Device Sequence Number1
Product Code FTT
UDI-Device Identifier07290101361695
UDI-Public07290101361695
Combination Product (y/n)N
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/25/2018
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 Expiration Date12/12/2017
Device Model NumberFGS-0312
Device Catalogue NumberFGS-0312
Device Lot Number33467Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/24/2017
Initial Date FDA Received09/19/2017
Supplement Dates Manufacturer Received04/25/2018
Supplement Dates FDA Received05/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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