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

Model Number	FGS-0450
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a lost report/data and the customer lost confidence in using the recorder.They were unable to download any of the patient's recordings.When the recorder was connected to a computer, they received an error "ce-do not support".A repeat procedure scheduled on another day was necessary.The recorder worked correctly during previous procedure.There was no patient and user harm.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo recorder was received for evaluation.The returned sample met specification as received by medtronic.The customer reported they had a lost report/data and the customer lost confidence in using the recorder.The reported condition was confirmed.The investigation found that in the bravo recorder data was deleted since was performed the new calibration by the user.This recorder was tested and it works as intended.The investigation found the most probable cause to be the user mishandling.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9775768
• Report Number: 9710107-2020-00094
• Device Sequence Number: 11334916
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2020

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
• Operator of Device: 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: 04/30/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/13/2020; 04/30/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/17/2020; 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1