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

Model Number FGS-0312

Device Problems Communication or Transmission Problem (2896); Missing Test Results (3267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

According to the reporter, they have a short study.The study was provided for review but no equipment is being returned.

Manufacturer Narrative

Device evaluation: the accuview graph from the study was returned for evaluation.The total time of the study was 52:13 hours as opposed to the recommended study time of 48 or 96 hours.Ph values were found to be normal throughout the study.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 in this manner, 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.A repeat procedure was performed and there was no harm to the patient and user.The recorder worked correctly during the previous procedure.The study was provided for review but no equipment is being returned.

Manufacturer Narrative

Additional information: 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, an accuview graph was provided by the customer for analysis.The customer reported barvo short study.The reported condition was confirmed.The investigation found that total time of the study is 52:13 hours, the ph with normal value but there ware ignores in the graphs.The investigation identified the root cause of the reported event to be bravo system communication failure.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 ; 15 hampshire street; mansfield, MA 02048 ; 7632104064
• MDR Report Key: 7192156
• MDR Text Key: 97866797
• Report Number: 9710107-2018-00108
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2018
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 35298Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2017
• 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: 35 YR