Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Nursery; Obstetrics and Gynecology; OR / Surgery; Pediatrics

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Hemorrhage; Mechanical (puncture, perforate, lacerate, break, cut, tear, nick, crush)

Support System Failures
Poor prepurchase evaluation; Use of inappropriate devices

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Failure to read label; Incorrect clinical use

UMDNS
Clamps, Circumcision [10-869]

Amputations with Use of Adult-Size Scissors-Type Circumcision Clamps on Infants



Hazard [Health Devices Jul 1995;24(7):286-7]

Problem

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.

Discussion

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.

Manufacturers' Action

We are aware of two manufacturers that offer both adult- and infant-size clamps, and both will begin identifying some units.

Recommendations

  1. 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.)
  2. 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.

UMDNS Term

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

Hemorrhage; Mechanical


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