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

Model Number FGS-0312

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had an incomplete/intermittent ph study.There was no harm caused to the patient.There will be a repeat procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had an incomplete/intermittent ph study.There was no harm caused to the patient.There will be a repeat procedure.

• Brand Name: VERSAFLEX
• 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: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7483084
• MDR Text Key: 107225627
• Report Number: 9710107-2018-00680
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 04/06/2018
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 35021Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/13/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 59