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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
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GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE Back to Search Results
Model Number FGS-0109
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the capsule has not dissolved after 48 hours of ingestion.Account manager advised that physician performed x-rays at 24 hours and 48 hours and capsule has not dissolved.They confirmed that the patient was asymptomatic and told the patient that it could take longer for the capsule to dissolve.Patient is currently stable.
 
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Brand Name
PILLCAM
Common Device Name
SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
MDR Report Key7436861
Report Number9710107-2018-00564
Device Sequence Number13512466
Product Code NSI
UDI-Device Identifier07290101360629
UDI-Public07290101360629
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K090557
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFGS-0109
Device Catalogue NumberFGS-0109
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2018
Initial Report FDA Received Date04/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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