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

Model Number	FGS-0312
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	06/05/2019
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 capsule which failed to attach.The patient was prepped for the procedure and a repeat procedure was performed, but there was no reported patient outcome.The delivery system and capsule will be returned for investigation.
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 capsule which failed to attach.The patient was prepped for the procedure and there was no harm to the patient.They used another capsule to complete the procedure and no repeat procedure was performed.The delivery system and capsule will be returned for investigation.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.Bravo device was received for evaluation.The returned sample met specification as received by medtronic.The customer reported that they have a capsule which failed to attach.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation found the device to function normally and within specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned.¿ these words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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: 8733380
• Report Number: 9710107-2019-00284
• Device Sequence Number: 2271668
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2019

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 Expiration Date: 01/29/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 44428Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 09/05/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/26/2019; 09/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1