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

Model Number FGS-0312

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the investigation is based on rapid ph graph review and on the graph it appears that the ph level drops below 4 ph and then increases to 8 ph.Dhr (device history record): bravo capsule, lot: 30496q, pass.Since there are ph level surges on the graph, it can be concluded that the capsule detached earlier.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, customer called to report a bravo capsule early detachment.Per tech, reviewed study submitted via email, tracings indicate the capsule detached shortly after it was placed.A repeat procedure was necessary.

• 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: 7018907
• MDR Text Key: 92601620
• Report Number: 9710107-2017-05610
• Device Sequence Number: 1
• Product Code: FTT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/10/2017

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: 02/01/2017
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 30496Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Manufacturer Received: 01/29/2017
• Initial Date FDA Received: 11/10/2017
• 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