MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO ; BRAVO PH CAPSULE

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 a bravo ph capsule that failed to attach.The pt was not injured following the procedure.

Manufacturer Narrative

(b)(4).Evaluation summary: one delivery system was returned to medtronic for evaluation.The delivery system was investigated visually for external damage.The delivery system was not bent and the plunger was not broken.The emergency release on the delivery system was not implemented.The wire that holds the capsule was completely off and the foam gasket was in good condition.The delivery system did not have any visible damage.As the product was received, the device functioned per specification.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.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 over ten years.No other known adverse events were reported.

• Brand Name: BRAVO
• Type of Device: BRAVO PH CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon bldg, new industrial park; p.o. box 258; yokneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD; 2 hacarmel street; new industrial park; yoqneam, 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4638899
• MDR Text Key: 21563554
• Report Number: 9710107-2015-00047
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 26232Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2014
• 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