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

Model Number FGS-0450

Device Problems Poor Quality Image (1408); High pH (2426)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the global complaint handling system.The product sample was not returned to the medtronic laboratory; however, a accuview graph was provided by the customer for analysis.The customer reported, they had a study with blue lines.The reported condition was confirmed.The investigation found that: a.The total study duration is 48 hours which indicates a performance of full study and proper function of bravo ph recorder, b.The ph capsule transmitted values at the first 11 hours of the study were within a normal ph range (5-7ph), and c.Starting from the 11 hour study and further, a progressive increase in ph reading above 8ph was noticed which continued to appear repetitively throughout the end of the study.The high ph readings can be noticed based on the blue lines which are presented on the graph due to the out of range ph measurements (above 8-9ph).The investigation identified the root cause of the reported event to be ph sensor of the capsule.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study with blue lines.Technical support retrieved a copy of the study and verified that the exclusions were due to the high ph readings.The recorder worked correctly during the previous procedure.There was no patient harm and a repeat procedure was necessary.

• 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: 8042395
• MDR Text Key: 126359598
• Report Number: 9710107-2018-01032
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 70 YR
• Patient Weight: 98