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

Model Number FGS-0634

Device Problems Failure to Transmit Record (1521); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

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 a failed study.After technical support reviewed the study, they found out that the study was short and it appeared that the capsule stopped transmitting.Technical support revised and deemed that the recorder was still working.A repeat procedure was necessary.There was no patient or user harm.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the global complaint handling system.The product sample was not returned; however, a accuview graph was provided by the customer for analysis.The returned sample did not meet specification as received.The customer reported short study.The reported condition was confirmed.The investigation found (b)(4) graph report review: 1.The total study duration is 06;09 hours instead of 24, 48 or 96 hours.2.The ph values throughout the study were within the normal range (5-7ph) until the study abruptly ended.3.Due to the fact that the only available information received from the customer is (b)(4) graph, the conclusion of the investigation cannot be positively determined.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a failed study.After technical support reviewed the study, they found out that the study was short and it appeared that the capsule stopped transmitting.Technical support revised and deemed that the recorder was still working.A repeat procedure was necessary.The recorder did work correctly during the previous procedure.There was no patient or user harm.

• Brand Name: BRAVO CF
• 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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8570859
• MDR Text Key: 143823630
• Report Number: 9710107-2019-00195
• Device Sequence Number: 1
• Product Code: FFT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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 Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/19/2019
• Supplement Dates FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• 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: 89 YR