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

Model Number FGS-0313

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Event Description

According to the reporter, after an esophageal procedure, the study was reviewed and it was noticed that the study had very high ph levels.A repeat procedure will be necessary due to the high ph levels.There was no harm to the patient or user due to the device malfunction.No known adverse events were reported.

Manufacturer Narrative

Investigation summary: the following investigation is based on accuview graph, risk assessment and ifu.The customer stated the study appears to have "very high ph." the total time of the study is 48 hours; full study.At the beginning of the study at 1:56:2pm, the ph dropped below 1ph until 5:09:56pm and then the ph rose above 8ph value, this indicates the bravo capsule attached early.If information is provided in the future, a supplemental report will be issued.

• 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 ; 2034925267
• MDR Report Key: 6687557
• MDR Text Key: 79088968
• Report Number: 9710107-2017-05316
• Device Sequence Number: 1
• Product Code: FFT
• 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,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 33894Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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: 47 YR
• Patient Weight: 82