Resectoscopes for Infants and Babies: Medical Device Safety Tips
MedSun: Newsletter #54, November 2010

FDA Medical Device Safety

This safety tip originally appeared in October's MedSun newsletter but the KidNet team would like to reiterate its importance for pediatric patient populations.

During cystoscopy and incision of a ureterocele in a 2-month old, the insulation slipped off the sheath and slid over the tip of the catheter exposing the hook electrode. Fortunately, the 2-month old was not injured. It was discovered that improper sequence of assembling the resectoscope was associated with this situation. This event reminds us of the importance to follow the proper sequence of steps outlined in the manufacturer’s user manuals when assembling resectoscopes for endoscopy procedures. For more information, please see the full Medical Device Safety Tip under Additional Information below.

Additional Information:

FDA Medical Device Safety. Resectoscopes for Infants and Babies - Medical Device Safety Tips. September 24, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm227105.htm

October 2010 MedSun Newsletter reference. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=53#2


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