MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problems Unspecified Infection (1930); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule never left the small bowel of the patient.The patient had a normal ct scan recently so a patency capsule was not used.However, the video showed pretty severe disease in the small bowel.The patient have become obstructed.The patient's current status was ok, but will still need a surgery as the capsule did not pass.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7718414
• MDR Text Key: 114973303
• Report Number: 9710107-2018-00859
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 7290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention