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

Model Number FGS-0450

Device Problems Poor Quality Image (1408); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The returned sample did not meet specification as received by medtronic.The reported condition was confirmed.The investigation could not determine a cause or a probable cause for the customer's report based on the information provided.This unit does not meet the requirements for a manufacturing or service failure therefore; a device history review or service history review is not required.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a short study of 27 hours.Technical support remotely accessed the computer to verify the study and verified that they had blue lines throughout the study.The customer stated that the patient saw "li" on the screen as well.The recorder worked correctly during the previous procedure.There was no patient or user harm and a repeat procedure was scheduled with additional anesthesia.

• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8880727
• MDR Text Key: 153947140
• Report Number: 9710107-2019-00363
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• 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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Date Device Manufactured: 03/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 74