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

Model Number FGS-0313

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the complaint tracking system.The product sample was not returned to the medtronic laboratory; however, a graph of the study was provided by the customer for analysis.The returned sample did not meet specification as received by.The customer reported that there were a number of "ignores" throughout the study.The reported condition was confirmed.The investigation confirmed the fault reported by the customer, but per the sample received the investigation cannot determine the cause for the early detach reported.The investigation identified the cause of the reported event to be capsule detached early.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, the study had a number of "blue lines".Technical support gained remote access and noticed that there were a number of "ignores" throughout the study.The patient needed a repeat procedure with anesthesia involvement.There was no patient injury.

• 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: 8800181
• MDR Text Key: 151410350
• Report Number: 9710107-2019-00338
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44089Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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: 76 YR