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

Model Number FGS-0312

Device Problem High pH (2426)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is based on accuview graph review, following review of study it appears that the ph level is above 8ph.Dhr (device history record): bravo capsule, lot: 29781qq, pass.The conclusion is high ph reading due to suspected capsule failure.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, customer called in to report they have a bravo study which the ph level was very high.Technical support was able to transfer study over for review and it appears that the ph level on this study stayed close to 9 throughout most of the study.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: 7019600
• MDR Text Key: 92601217
• Report Number: 9710107-2017-05613
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 29781Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Date Manufacturer Received: 01/29/2017
• 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