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

Model Number FGS-0313

Device Problem High Readings (2459)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: though the capsule was not received for evaluation, the study was received.Based on the data that was collected during the procedure, it was evident that the study duration was 95.48 hours.The study started with normal ph value; after 72 hours, the ph dropped below ph 2 and then then ph raised above ph 8 with missing values.This indicates that the capsule detached early, continued to the stomach which has a lower ph and then to the bowel, confirming the high ph.The root cause for the missing ph values could not be determined.A review of the device history record indicating that the product was released meeting finished product specifications.

Event Description

According to the reporter, during an esophageal procedure, there was a high level of artifact during the study.The doctor performed a repeat procedure on this patient.No other known adverse events were reported.

• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6192554
• MDR Text Key: 62909537
• Report Number: 9710107-2016-01150
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2016
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 29781Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2015
• 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