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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; CAMERA, STILL, SURGICAL
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GIVEN IMAGING LTD., YOQNEAM BRAVO; CAMERA, STILL, SURGICAL Back to Search Results
Model Number FGS-0312
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation based on accview graph, total time of the procedure is 48 hours, the ph value at below 4 ph, and there is ignores in the procedure.No indicated to capsule detached earlier.
 
Event Description
According to the reporter, customer called to report a possible bravo capsule detached early study.Upon review of the study the failure symptom was determined to be due to bravo low ph reading.A repeat procedure was necessary due to the malfunction.
 
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Brand Name
BRAVO
Type of Device
CAMERA, STILL, SURGICAL
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
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925297
MDR Report Key7019523
MDR Text Key92643253
Report Number9710107-2017-05612
Device Sequence Number1
Product Code FTT
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2016
Device Model NumberFGS-0312
Device Catalogue NumberFGS-0312
Device Lot Number29519Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2017
Date Manufacturer Received01/29/2017
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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