MAUDE Adverse Event Report: GIVEN LTD (ISRAEL) BRAVO PH CAPSULE DELIV DEV 1-PK; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during an esophageal procedure, the bravo capsule yielded a short study.The study was only 15 minutes long with a straight red line.The patient kept the recorder the entire 48 hours.The patient had called the doctor but the doctor did not get the call and the patient was advised to continue wearing the equipment.The account confirmed that a repeat procedure was necessary.No other known adverse events were reported.

Manufacturer Narrative

Evaluation summary: thought he defective device was not provided for evaluation, a copy of the data was received.Based on the data collected, the recording was 00:14 minutes instead of the intended 24, 48 or 96 hours.Due to the limited data available the conclusion of the investigation is that the cause of the malfunction could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO PH CAPSULE DELIV DEV 1-PK
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer (Section G): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 6010815
• MDR Text Key: 56806911
• Report Number: 9710107-2016-01040
• Device Sequence Number: 1
• Product Code: FFT
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• 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: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1