MAUDE Adverse Event Report: GIVEN IMAGING, INC. PILLCAM; SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE

Model Number	FGS-0155
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Twenty-four hour ph bravo capsule not working once implanted into patient esophagus.Transistor box read" capsule mismatch".It was determined the correct capsule number was entered and appeared working prior to esophageal placement.A new capsule needed to be placed, which worked successfully using the same box recorder.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7641224
• Report Number: 7641224
• Device Sequence Number: 2324415
• Product Code: NEZ
• UDI-Device Identifier: 07290101363200
• UDI-Public: (01)07290101363200
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/19/2018
• Report Date (Section F): 06/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: FGS-0155
• Device Catalogue Number: FGS-0155
• Device Lot Number: 40135Q
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/19/2018