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

Catalog Number FGS-0450

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the recorder displayed 4 zeros when study was started.The recorder has lost calibration data, possibly due to the user restraint calibration, but there is no way to confirm this.The reporter also confirmed that a repeat bravo procedure was necessary to place the new bravo capsule.

• 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 rd; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6036699
• MDR Text Key: 57727191
• Report Number: 9710107-2016-01047
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1