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

Model Number FGS-0313

Device Problems Loss of or Failure to Bond (1068); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, they had a capsule which failed to attach.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure, an endoscopy had been performed prior to the procedure and showed the esophagus to be normal, and no lubrication was used to facilitate placement of the capsule.

Manufacturer Narrative

Evaluation summary one bravo ph capsule delivery device and one capsule were received for investigation.The capsule was not attached to the delivery device.Visual inspection did not reveal any damage and appears to have functioned within specification.Functional testing could not be performed because this is a single use device and once the capsule is delivered it cannot be functionally tested.Investigation conclusion for the failure to attach could not be reliably determined.We were unable to confirm the customer¿s report.If information is provided in the future, a supplemental report will be issued.

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 longbiw drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7706629
• MDR Text Key: 114853550
• Report Number: 9710107-2018-00841
• 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,Followup
• Report Date: 10/03/2018

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 Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 39869Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 08/08/2018
• Supplement Dates FDA Received: 08/20/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: No
• 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