Amputations with Use of Adult-Size Scissors-Type Circumcision Clamps on Infants
Hazard [Health Devices Jul 1995;24(7):286-7]
We have become aware of several incidents involving the use of adult-size,
scissors-type circumcision clamps for infant circumcision procedures. In these cases, part
of the infant's glans penis was amputated along with the foreskin. Issues of clamp size
versus patient size appear to be related to the incidents. The type of clamp used in these
procedures is produced by several manufacturers.
The scissors-type circumcision clamp, which
was invented more than 60 years ago, consists of two jaws hinged together at one
end. One face of the clamp is flat, and the obverse is concave. The clamp's jaws
can be held closed with a cam-lever-bar assembly attached to the end opposite
the hinge (see figure).
Scissors-type circumcision clamps are currently available in two sizes,
adult and infant (although not all manufacturers produce both sizes). The width of the jaw
opening, which is the main difference between these types, is 1.5 to 2.4 mm for the infant
size and 3.0 to 5.0 mm for the adult size. The jaw opening of the infant-size clamp (2.4
mm in the original design) allows only the infant's foreskin to be pulled into the
opening; it tends to exclude the glans. However, some physicians prefer to use the
adult-size clamp on infants because its larger opening enables the tissue to slide more
easily into the jaws. The adult-size clamp opening, however, allows the infant's glans
penis to be pulled in along with the foreskin; thus, care must be exercised to prevent
this from occurring.
Many users are not aware of the hazard involved in the use of an
adult-size clamp on an infant—or even that the clamp is available in two sizes. This
may be because the adult- and infant-size clamps are not marked or labeled as such. In
addition, the two types are similar in appearance, although the adult-size clamp is
approximately 25 mm longer than the infant size.
We are aware of two manufacturers that offer both adult-
and infant-size clamps, and both will begin identifying some units.
- Determine the size of each scissors-type circumcision
clamp in use and permanently mark each clamp as ADULT if the jaw opening is
greater than or equal to 3 mm or INFANT if the opening is 1.5 to 2.4 mm. (A
standard electrical engraving tool can be used to mark the units.)
- Inform users of the risk of infant glans penis amputation when an
adult-size clamp is used. If a decision is made to continue using adult-size
clamps on infants, special care must be exercised to exclude the glans from
the jaw opening when clamping the foreskin.
Clamps, Circumcision [10-869]
Cause of Device-Related Incident
Device factor: Design/labeling error
User errors: Failure to perform pre-use inspection;
Failure to read label; Incorrect clinical use
Support system failures: Poor prepurchase evaluation; Use of inappropriate devices
Mechanism of Injury or Death