MAUDE Adverse Event Report: GIVEN LTD (ISRAEL) BRAVO PH CAPSULE DELIEVERY DEV, 1-PK; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Separation Failure (2547)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during an esophageal procedure, the bravo capsule failed to detach and the device operator had to employ an emergency release procedure.There was no harm ot the patient and a repeat procedure was not performed because this capsule placed okay.Intervention was not required.There was nothing unusual about the patient or the procedure itself that may have led to this event.An endoscopy was performed prior to the bravo procedure, the esophagus appeared to be normal.The bravo user has been using this procedure for years.Lubricant was used to facilitate capsule replacement.

Manufacturer Narrative

(b)(4).Evaluation summary: one delivery system was received for evaluation and investigated visually for external damage.The capsule was not received.The delivery system was disinfected and the lot number and id# matched the information provided by the initial reported.The delivery system was not bent and the plunger was not broken.The plunger rotated more than 1/8 turn.The emergency procedure was not implemented.The delivery system did not have any other visible damage.Per the condition in which the device was received, the delivery system and capsule seemed to be functioning per specification.A review of the device history records for the provided lot / serial number was completed and indicates all parameters and acceptance criteria for entries potentially pertinent to the reported event were within specified limits at the time of release.

• Brand Name: BRAVO PH CAPSULE DELIEVERY DEV, 1-PK
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer (Section G): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6053417
• MDR Text Key: 58307067
• Report Number: 9710107-2016-01059
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 31835Q
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2016
• 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