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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
Laparoscopic Cholecystectomy Kit
Device Brand Name:
Laparoscopic Cholecystectomy Kit
Device Manufacturer's Name:
LeeSar, Inc.
Date of this Report:
(mm/dd/yyyy)
11/19/2015
Describe the Event
or Problem:
Over a period of time, our OR staff have identified incorrect sponge counts right out of the package. We have been reporting them via MedSun. Our custom surgical pack operations company asked for a meeting regarding our problems with sponge counts and we did so this month. They explained quite in detail what they have been doing for the last few months to mitigate this problem. In summary, our vendor puts together the packs, opens the sponge packs received from the manufacturer and counts twice on their assembly line. One person counts, then it goes to the next person to count. Our OR staff educators have shared this with our staff; our counts are done by laying out the sponges separately on a flat surface. At this time, we are seeing fewer incidences of incorrect numbers of sponges in packs and we hope the problems have been resolved.
the device(s) may have
caused or contributed to:
Potential for patient harm
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