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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 RFB-0450
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, the recorder was returned from the patient with a steady red light, but it would not turn on. They attempted to restart the recorder, multiple times, but all attempts failed. Technical support had the customer reset the recorder, but it still failed. The recorder contained the patient data. A repeat procedure will be performed. The customer stated that recorder worked correctly during the previous procedure. There was no patient and user injury.

 
Manufacturer Narrative

Additional information: first name last name, phone#),(e-mail). If information is provided in the future, a supplemental report will be issued.

 
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Brand NameBRAVO
Type of DeviceCAMERA, 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
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key8381933
MDR Text Key137532322
Report Number9710107-2019-00075
Device Sequence Number1
Product Code FTT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRFB-0450
Device Catalogue NumberRFB-0450
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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