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

Model Number FGS-0313

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Discomfort (2330); Choking (2464); Radiation Exposure, Unintended (3164)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: na (other).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule was placed in the esophagus without disclosing that the patient had a metal allergy and was experiencing chest pain which radiated to her back.It was noted that the patient was having dysphagia/choking prior to the procedure.A chest x-ray was performed and confirmed that the capsule is attached in the lower esophagus.The physician removed the capsule with a snare, nudged it into the stomach, and then removed it with a roth retrieval basket.There were no signs of an allergic reaction at the site.The patient reported an immediate improvement in her symptoms of chest discomfort, and demanded to keep the capsule in a container.However, it had already been sent to the pathology department and confirmed that it was a ph capsule.

Manufacturer Narrative

Corrected information: 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: 7719598
• MDR Text Key: 115013151
• Report Number: 9710107-2018-00861
• 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: 10/05/2018

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