MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE

Model Number	FGS-0109
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Abdominal Pain (1685); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title detection of small bowel mucosal healing and deep remission in patients with known small bowel crohn¿s disease using biomarkers, capsule endoscopy, and imaging source the american journal of gastroenterology, volume 110, 2015(1316-1323) date of publication: 28 july 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed, one patient had a symptomatic patency capsule retention manifesting with abdominal pain and vomiting.The patient was treated with corticosteroids with subsequent resolution of the symptoms within 2 days.Article: detection of small bowel mucosal healing and deep remission in patients with known small bowel crohn¿s disease using biomarkers, capsule endoscopy, and imaging author: uri kopylov , md, year: 2015 september volume110.

• 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 Key: 8035216
• Report Number: 9710107-2018-01022
• Device Sequence Number: 1187700
• Product Code: NSI
• UDI-Device Identifier: 07290101360629
• UDI-Public: 07290101360629
• Combination Product (Y/N): N
• PMA/510(K) Number: K090557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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 Number: FGS-0109
• Device Catalogue Number: FGS-0109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention