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

Model Number FGS-0313

Device Problems Failure to Transmit Record (1521); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule could not be picked up by the recorder after it was placed in the patient.The customer confirmed that there was a mismatch id error message.The customer used a second capsule to complete the procedure.The study will be repeated.There was no patient injury.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel and bravo device arriving in bio lab.Bravo device (capsule and delivery) was received for evaluation.Since inadequate sample was returned for investigation it is impossible to determine if product meet specs or not.The visual inspection found no issues.The customer reported bravo fail to transmit.An investigation of the returned equipment was not performed since the sample was sent as bio-hazard contaminated to the lab and is not a bio-hazard device.Evaluation was not performed since the product sample did not arrive for investigation in a proper manner allowing investigation.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided and sample received.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule could not be picked up by the recorder after it was placed in the patient.The customer confirmed that there was a mismatch id error message.A repeat procedure at another time was not necessary as the customer used another capsule to complete the procedure.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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8780374
• MDR Text Key: 150705395
• Report Number: 9710107-2019-00326
• 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,Followup
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 43593Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• 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