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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING INC.(COVIDIEN LP) PILLCAM DR3; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
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GIVEN IMAGING INC.(COVIDIEN LP) PILLCAM DR3; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE Back to Search Results
Model Number DR3
Device Problems No Display/Image (1183); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/23/2021
Event Type  malfunction  
Event Description
Pillcam issues: pill camera is functioning properly until the patient (pt) swallowed it, then the pillcam monitor stopped transmitting, lost the image and the light turned from rapidly flashing blue (the color desired) to intermittent yellow.I tried adjusting the sensor belt and monitor without any change.I contacted (b)(6) technical support and notified doctor of the issues.Returning to the pt's room, i found the monitor had stopped responding.I changed out all of the equipment, paired the pillcam with the monitor and belt.Everything was functioning as it should until the pt swallowed the pillcam, and the exact same thing happened as it did with the first pill camera.
 
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Brand Name
PILLCAM DR3
Type of Device
SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
Manufacturer (Section D)
GIVEN IMAGING INC.(COVIDIEN LP)
15 hampshire street
mansfield MA 02048
MDR Report Key12868500
MDR Text Key281210463
Report Number12868500
Device Sequence Number1
Product Code NEZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2021,11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDR3
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2021
Date Report to Manufacturer11/24/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age33215 DA
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