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

Model Number	FGS-0662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Radiation Exposure, Unintended (3164)
Date of Event	05/03/2019
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 patient complained of nausea, vomiting and abdominal pain for 2 days and went to the emergency room.The adverse events occurred within 4 days post capsule procedure, preceded by bowel prep.The patient had 2 days extend hospitalization.A computed tomography (ct) abdomen revealed capsule was in the large bowel and no evidence of small bowel obstruction.The capsule sited on ct 4 days post index procedure and not considered a capsule retention.Exacerbation of crohn's disease, however possible relatedness to capsule only due to capsule was seen in the large bowel, but the patient passed the capsule naturally.No repeat procedure was needed.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8716327
• Report Number: 9710107-2019-00269
• Device Sequence Number: 2268174
• Product Code: NEZ
• UDI-Device Identifier: 07290110360559
• UDI-Public: 7290110360559
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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 Expiration Date: 10/31/2019
• Device Model Number: FGS-0662
• Device Catalogue Number: FGS-0662
• Device Lot Number: 43278U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/20/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 64