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

Model Number FGS-0312

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a bravo capsule which failed to attach.It was reported there was no harm to the patient, no medical intervention was required and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the bravo procedure and showed the esophagus to be normal.No lubricant was used to place the capsule and the defective device will be returned for investigation.

Manufacturer Narrative

Investigation summary: it was reported that one bravo ph capsule failed to detach from the delivery device onto the patient's esophagus.One bravo ph capsule delivery device was received for investigation.The capsule was not attached to the delivery device.The capsule was received for investigation.Visual inspection did not reveal any damage, and appears to have functioned within specification.Functional testing could not be performed because this is a single use device and once the capsule is delivered it cannot be functionally tested.Investigation conclusion for the failure to attach could not be reliably determined.Additionally, a review of the device history record was performed and indicates that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Investigation summary: it was reported that one bravo ph capsule failed to attach from the delivery device onto the patient's esophagus.One bravo ph capsule delivery device was received for investigation.The capsule was not attached to the delivery device.The capsule was received for investigation.Visual inspection did not reveal any damage, and appears to have functioned within specification.Functional testing could not be performed because this is a single use device and once the capsule is delivered, it cannot be functionally tested.Investigation conclusion for the failure to attach could not be reliably determined.Additionally, a review of the device history record was performed and indicates that the product was released meeting finished product specifications.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: 6869634
• MDR Text Key: 86339583
• Report Number: 9710107-2017-05480
• Device Sequence Number: 1
• Product Code: FTT
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2017
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 31809Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 10/25/2017; 11/26/2017
• Supplement Dates FDA Received: 11/02/2017; 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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