Mismatching Medical Devices and Accessories
MedSun: Newsletter #26, July 2008

Pennsylvania Patient Safety Authority
PA-PSRS Patient Safety Advisory

We are posting this information because we continue to see reports describing injuries to patients from the use of incompatible device parts. The article entitled, "Mismatching Medical Devices & Accessories," from the Pennsylvania Patient Safety Authority describes device issues with the Gomco circumcision clamp, which the FDA has issued a Public Health Notification in 2000 online available (see Additional Information below). This article also describes patient injury when a Padgett blade was inserted into a Zimmer dermatome device. We continue to see reports of this nature. You may read a recent MedSun report online available (see Additional Information below).

Additional Information:

Mismatching Medical Devices and Accessories. Pennsylvania Patient Safety Authority. PA-PSRS Patient Safety Advisory. March 2005, Volume 2, Issue 1.

http://www.psa.state.pa.us/psa/lib/psa/advisories/v2n1march2005/vol_2-1-march-05-article_g-mismatching.pdf

Potential for Injury from Circumcision Clamps. FDA Public Health Notification. August 2000.
http://www.fda.gov/cdrh/safety/circumcision.html

MedSun Report
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D%5F%3B%25%5F8%20%0A


MedSun Newsletters are available at www.fda.gov/cdrh/medsun