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

Model Number	DR3
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came in for an outpatient pill camera procedure on (b)(6) 2020.The patient called around 11 am and stated that his machine turned off shortly after he had a bowel movement.Manufacturer was called and they stated that the patient probably passed the pill in their bowel movement and that it is normal for the machine to shut off when the pill gets out of range (flushed) and to have them return the equipment.The information was downloaded immediately and gastroenterologist was notified.The next morning, it was noted that the machine only had 2 bars for battery even though it charged overnight.When gastroenterologist read the results on (b)(6), he said that the pill had not been passed as suspected and that the test stopped while in the pill was still in the intestines and that the test needs to be repeated.Fda safety report id# (b)(4).

• Brand Name: PILLCAM RECORDER
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING, INC. ; mansfield MA 02048
• MDR Report Key: 10355717
• Report Number: MW5095837
• Device Sequence Number: 2927107
• Product Code: NEZ
• UDI-Device Identifier: 07290101362951
• UDI-Public: (01)07290101362951
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: Lay User/Patient
• Device Model Number: DR3
• Device Catalogue Number: FGS-0347
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR