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

Model Number FGS-0313

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

This report is based on information provided by investigation personnel.The product sample was not returned to the laboratory; however, a picture was provided by the customer for analysis.The sample did not meet specification.The picture sample showed bravo study missing traces.The reported condition was confirmed.The investigation found the following: according to accuview graph , the total of the study was 47:32 hours, however after 2 hours of study, there was no ph values reading.Recorder failure ¿ due to a failure in the internal components inside the recorder, the ability to pick bravo capsule signal was damaged.Capsule failure - due to failure on capsule¿s internal components, the ability of the capsule to function properly was damaged.Because information attached to sr from customer includes only accuview graph, the conclusion of the investigation cannot be positively determined.The investigation identified the root cause of the reported event to be bravo system communication failure.The failure identified on this customer returned sample is a known issue and is addressed in the risk management file.No update to the risk management file is required at this time.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study with no tracings.The study was received and recording showed only a few minutes of valid data and there was no tracings for the rest of the study.There was no patient harm.

• 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 ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7611341
• MDR Text Key: 111708743
• Report Number: 9710107-2018-00770
• 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: 06/18/2018

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-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 39869Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/18/2018
• 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 Weight: 109