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

Model Number BRAVO PH CAPSULE

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 patient 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

The physician kept the delivery system as straight as possible during the procedure.The patient did not cough, move, or sneeze at the time the plunger was pressed.The physician only used one hand to perform the procedure and confirmed to have seen the width mark on the plunger, confirming that the capsule was completely released from the delivery system.

• Brand Name: BRAVO
• Type of Device: BRAVO PH CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building; new industrial park, p.o 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: 4801924
• MDR Text Key: 5830359
• Report Number: 9710107-2015-00140
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2016
• Device Model Number: BRAVO PH CAPSULE
• Device Catalogue Number: FGS-0313
• Device Lot Number: 27262Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2015
• 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