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	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was scheduled for an m2a study but we were unable to capture data/read study.Patient will need to repeat study at different time.

• 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: 7826086
• Report Number: 7826086
• Device Sequence Number: 16755914
• Product Code: NSI
• 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): 08/06/2018
• Report Date (Section F): 08/06/2018

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: 40041S
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• 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: 08/06/2018