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

Model Number	FGS-0109
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
Date of Event	05/30/2018
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 experienced projectile vomiting of slimy material and epigastrium pain.Technical support forwarded the complaint to the medical staff.The customer had a conversation with the medical staff through email and stated that an abdominal x-ray was performed and observed two rods.On the recent kidney, ureter and bladder ultrasound, the radiologist stated that the capsule appeared to be separated and some of it was lodged in the gastroesophageal junction while other bits of it were in the colon.The patient was feeling better.

• 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: 7620093
• Report Number: 9710107-2018-00779
• Device Sequence Number: 1396721
• Product Code: NSI
• UDI-Device Identifier: 07290101360629
• UDI-Public: 07290101360629
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 06/04/2018
• Initial Report FDA Received Date: 06/20/2018
• 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
• Patient Age: 60 YR