MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO CAMERA, STILL, SURGICAL

Model Number RFB-0450

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  Malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the recorder was returned from the patient with a steady red light, but it would not turn on. They attempted to restart the recorder, multiple times, but all attempts failed. Technical support had the customer reset the recorder, but it still failed. The recorder contained the patient data. A repeat procedure will be performed. The customer stated that recorder worked correctly during the previous procedure. There was no patient and user injury.

Manufacturer Narrative

Additional information: first name last name, phone#),(e-mail). If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: CAMERA, STILL, SURGICAL
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8381933
• MDR Text Key: 137532322
• Report Number: 9710107-2019-00075
• Device Sequence Number: 1
• Product Code: FTT
• 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

• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 03/01/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: RFB-0450
• Device Catalogue Number: RFB-0450
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown