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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 Loss of or Failure to Bond (1068)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
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.There was no reported patient outcome.
 
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.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure, scope was used by the physician to determine capsule placement, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule.
 
Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.Bravo delivery system was received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found broken plunger.The customer reported they had a capsule which failed to attach.The investigation found the plunger rotated more than 1/8.The investigation identified the cause of the reported event to be user mishandling.The user has contradicted the instructions for use (ifu).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.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure, scope was used by the physician to determine capsule placement, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.
 
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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 Key8768636
MDR Text Key150299513
Report Number9710107-2019-00315
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101361688
UDI-Public07290101361688
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 Physician
Type of Report Initial,Followup,Followup
Report Date 08/27/2019
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 Date03/19/2020
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number44907Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2019
Initial Date FDA Received07/08/2019
Supplement Dates Manufacturer Received06/20/2019
08/06/2019
Supplement Dates FDA Received07/10/2019
08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2019
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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