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

Model Number FGS-0313

Device Problem Missing Test Results (3267)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

Following the above investigation ignores appears when patient was in supine or meal status apparently the bravo recorder was distance from patient body.According to the investigation and the procedure that product are released only after they have been tested and released we consider the product met the specification.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, the customer called with a bravo study that lasted only 22 hours of the 48 hours necessary to capsule data.There are also missing tracing throughout the study.The customer reported that a repeat procedure was necessary due to the short study.

• 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: 7172298
• MDR Text Key: 96637942
• Report Number: 9710107-2018-00041
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2018

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: 05/10/2017
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 31307Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2016
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 01/08/2018
• 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