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U.S. Department of Health and Human Services

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Type of Device:
system, imaging
Device Brand Name:
PillCam
Device Manufacturer's Name:
GIVEN IMAGING, INC.
Date of this Report:
(mm/dd/yyyy)
11/06/2014
Describe the Event
or Problem:
RN called Endoscopy to notify us that the video capsule recorder had stopped functioning. The recorder was brought back to Endo and was found to be in working condition, battery was charged and we could not find anything wrong. This RN went back to the pt bedside, re-connected the recorder and the recorder continued the study. Upon upload of pt study that only the later part of the study was captured. Missing several hours of the study. The capsule was never paired with the recorder causing the recorder to shut down. The staff was immediately notified by newsletter update via email. A step-by-step sign was placed in the procedure room where the capsule is administered. operator error The device is new equipment. All staff attended a 1-on-1 in-service. The staff involved was in-serviced again. Step by step instructions were posted next to the equipment. A staff alert was published in the weekly newsletter. Staff will be worked with on upcoming cases. Study needed to be repeated.
the device(s) may have
caused or contributed to:
Potential for patient harm
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