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U.S. Department of Health and Human Services

Medsun Reports

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Type of Device:
SUTURE, ABSORBABLE, NEEDLE
Device Brand Name:
COATED VICRYL
Device Manufacturer's Name:
ETHICON, Inc.
Date of this Report:
(mm/dd/yyyy)
10/01/2015
Describe the Event
or Problem:
Doctor was suturing fascia layer, when the CT-1 (36mm 1/2c Taper needle) became bent out of its original form Doctor made an attempt to reload/reposition the suture with the needle driver, at which point the needle broke cleanly into two pieces, away from the incision site, but remained on the sterile field. Pieces(2) were immediately identified and retrieved by both physicians and carefully returned to the Surgical Tech for counting purposes.There was no harm to patient or healthcare worker
the device(s) may have
caused or contributed to:
Potential for patient harm
Potential harm to a health care provider
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