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

Model Number FGS-0313

Device Problem No Display/Image (1183)

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

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a procedure, the bravo study presented itself with several vertical blue lines.Due to the alleged device malfunction, a repeat procedure is necessary.There was no harm to the patient or user.No other known adverse events were reported.

• Brand Name: BRAVO PH CAPSULE DELIV 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 ; 195 mcdermott st; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6124013
• MDR Text Key: 60752204
• Report Number: 9710107-2016-01098
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2017
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 32111Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 98