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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
Laparoscope, General & Plastic Surgery
Device Brand Name:
PDB
Device Manufacturer's Name:
Covidien
Date of this Report:
(mm/dd/yyyy)
03/04/2015
Describe the Event
or Problem:
A Covidien Kidney Shape Balloon disassembled while inside patient during laparoscopic surgery. The balloon and sheath separated from the shaft of the device. Both were removed intact. No patient was harmed.
the device(s) may have
caused or contributed to:
Potential for patient harm
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