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

Model Number FGS-0312

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/08/2019

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 detach.There was no reported patient outcome.

Manufacturer Narrative

Additional information: 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 detach.When they took out the delivery system from the patient, the capsule was still on the delivery system.There was no harm to the patient, no intervention was required, and no repeat procedure was performed as they used another capsule to complete the procedure.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule and the delivery system and the capsule will not be returned for investigation.

Manufacturer Narrative

Additional info: 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 detach.When they took out the delivery system from the patient, the capsule was still on the delivery system.There was no harm to the patient, no intervention was required, and no repeat procedure was performed as they used another capsule to complete the procedure.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitateplacement of the capsule and the delivery system and capsule will not be returned for investigation.

Manufacturer Narrative

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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8289476
• MDR Text Key: 134494607
• Report Number: 9710107-2019-00045
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2019

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 Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/20/2019; 04/11/2019; 05/16/2019
• Supplement Dates FDA Received: 03/15/2019; 04/12/2019; 06/10/2019
• 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