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

Model Number	FGS-0501
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	08/14/2018
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 complained of coughing a lot and that the capsule felt stuck after ingesting it.The customer informed that the recorder was flashing yellow and went to adaptive frequency response to an exclamation mark.Technical support informed the customer that since the recorder was flashing yellow for 20-30 minutes, the unit went into end of procedure mode and had stopped recording.As per the customer, they performed an esophageal gastroduodenoscopy and did not see the capsule, so they will have the patient take x-rays to confirm if the capsule was passed before having the patient ingest a second capsule.Tech support informed the customer to create the video and recheck in the patient to see if they can resume recording.The x-ray findings showed that the capsule was in the right bronchus.There was no reported patient outcome.

• 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: 7929717
• Report Number: 9710107-2018-00971
• Device Sequence Number: 1913963
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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-0501
• Device Catalogue Number: FGS-0501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/03/2018
• 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