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

Model Number FGS-0312

Device Problems Premature Activation (1484); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the study failed as the capsule dropped into the patient's stomach, no medical intervention was required to remove the capsule.There was no harm to the patient or user due to the alleged device malfunction.A repeat procedure will be necessary.

Manufacturer Narrative

Device investigation: the accuview graph from the study was returned for evaluation.The total time of the study was 36:39 hours as opposed to the recommended study time of 48 or 96 hours.The ph readings were found to be at normal values throughout the study.Because information sent from the customer includes only accuview graph, the conclusion of the investigation cannot be positively determined.Although a root cause could not be determined, when the recording stops in this manner, it can be caused by the following: recorder battery failure; a failure of the recorder to receive capsule signals due to failure of recorder components; capsule failure; capsule detached early investigation conclusion for the failure to attach could not be reliably determined.Because the lot number of the capsule was not provided, a dhr review could not be performed.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: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925297
• MDR Report Key: 6968275
• MDR Text Key: 90748614
• Report Number: 9710107-2017-05575
• Device Sequence Number: 1
• Product Code: FTT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 33467Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1