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

Model Number FGS-0313

Device Problem Low pH (4005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2018

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 picture of the study was provided by the customer for analysis.The reported condition was confirmed.The investigation confirmed the fault described by the customer, but per the sample received cannot determine from investigation what was the caused for the early detach.The investigation identified the root cause of the reported event to be capsule detached early.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study with low ph reading.The physician checked the placement of the capsule prior to starting study and verified it was in the correct position.A copy of the study was provided for review and technical support confirmed the low ph reading.The recorder worked correctly during the previous procedure.The patient had a repeat procedure performed on a different day.

• 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: 8396228
• MDR Text Key: 138012856
• Report Number: 9710107-2019-00081
• 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: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 41445Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Date Device Manufactured: 07/19/2018
• 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: 52 YR
• Patient Weight: 76