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

Model Number FGS-0450

Device Problems Date/Time-Related Software Problem (2582); Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

The accuview graph from the study was returned for evaluation.Because information sent from the customer includes only the accuview graph, the conclusion of the investigation cannot be positively determined.Although a root cause could not be determined, when the recording stops early, it can be caused by the following: ¿ recorder battery discharge ¿ if battery was not replaced before beginning of the study.¿ recorder malfunction ¿ 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 or the capsule detached early.Investigation conclusion for the short study could not be reliably determined.A review of the device history record was performed and indicates that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a short study which was only 11 hours and 1 minute.The patient did not report any issues with the recorder during the procedure.Technical support connected to the computer and attempted to upload the study for two more times and each time, it was only 11 hours long.The customer contacted the patient, but they did not report anything unusual about the procedure.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure with anesthesia will be necessary.

Manufacturer Narrative

Corrected information:if information is provided in the future, a supplemental report will be issued.

• 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: 7716626
• MDR Text Key: 115106479
• Report Number: 9710107-2018-00853
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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: 44 YR