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 Codes	Hernia (2240); No Code Available (3191)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
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 became lodged in the patient's hernia.The patient was inquired if he can ingest another capsule and was informed that the patient should ingest another capsule if it has been verified that the capsule has been passed or removed.It was stated that the physicians will remove the capsule and perform the study again once the capsule has been passed or removed from the patient.
Additional Manufacturer Narrative
Additional information: patient code - (b)(6) (stuck due to patient's pre-existing hernia).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the capsule became lodged in the patient's hernia.It was noted that the patient had a pre-existing hernia.The capsule has yet to pass from the patient and sales representative stated that the physicians will remove the capsule and perform the study again once the capsule has been passed or removed from the patient.There was no patient and user harm.
Additional Manufacturer Narrative
Additional information: (first name, last name), (email), if information is provided in the future, a supplemental report will be issued.

• 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: 8370837
• Report Number: 9710107-2019-00068
• Device Sequence Number: 1332419
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 05/06/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/02/2019; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1