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	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A pillcam capsule endoscopy was planned.The first pillcam we used had difficulty syncing with the capsule data collecting device, so a second pillcam was then obtained.This second pillcam synced with the device, and an upper endoscopy was done to place the pillcam.The next day, after the capsule data was reviewed, it was discovered that the data collection was incomplete.There were large sections where recording appears to be missing starting at about 2 hr and 45 mins into the study.Then the recording resumes for about 3 mins at 3 hr 12 mins and then stops recording again at 3 hr 15 mins.The capsule stops recording altogether at about 3 hr 45 mins.

• 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: 7854718
• Report Number: 7854718
• Device Sequence Number: 13948362
• 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): 08/29/2018
• Report Date (Section F): 08/29/2018

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: 40764S
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2018
• 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: 08/29/2018