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 patient was not injured following the procedure.

Manufacturer Narrative

(b)(4).Evaluation summary: one delivery system was returned to medtronic for evaluation.The capsule was not returned for investigation.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.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

The capsule fell off after placing it, when the patient was in recovery.No known adverse events were reported.

• Brand Name: BRAVO
• Type of Device: BRAVO PH CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building, 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: 4737223
• MDR Text Key: 5888451
• Report Number: 9710107-2015-00120
• 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: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2015
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 25725Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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