MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; CAMERA, STILL, SURGICAL

Model Number FGS-0312

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

According to the reporter the customer had a bravo capsule which failed to attach, no harm was caused to the patient and a repeat procedure was performed.It was reported no intervention was necessary to correct an injury and nothing unusual about the patient or the procedure which led to the incident.Prior to the procedure an endoscopy was performed and the esophagus appeared to be normal.The physician has been performing the bravo procedure for many years, and was trained by a given representative.It is unknown what the vacuum source was or the pressure before the procedure.The physician is not clear to what caused the failure to attach, they felt that everything went well during the process, but then it felt like it was stuck after the deployment.The device is expected to be returned for evaluation.

Manufacturer Narrative

Investigation summary: it was reported that one bravo ph capsule failed to attach to the patient 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: CAMERA, STILL, SURGICAL
• 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: 6844331
• MDR Text Key: 85120059
• Report Number: 9710107-2017-05466
• Device Sequence Number: 1
• Product Code: FTT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• 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
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2018
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 35290Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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