MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO

Model Number FGS-0313

Device Problems Failure To Adhere Or Bond (1031); Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported on bravo ph capsule that failed to detach.The pt was not injured following the procedure.

Manufacturer Narrative

(b)(4).There was no required intervention to prevent permanent impairment/damage in this case.The information was updated in this supplemental.

Event Description

A repeat procedure was necessary due to the alleged device malfunction.Intervention was not required.There was nothing unusual about the patient or procedure itself that may have led to this event.An endoscopy was performed prior to the procedure and the esophagus appeared to be normal.The device operator has been performing this procedure for eleven years.No known adverse events were reported.

• Brand Name: BRAVO
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon bldg, new industrial park, po box 258; yokneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD.; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4652398
• MDR Text Key: 15839739
• Report Number: 9710107-2015-00059
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2015
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 24892Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention