The FDA is alerting health professionals to the potential for injury from two commonly used circumcision clamps, the Gomco®/gomco-type and Mogen®/mogen-type clamps.
Both are widely used during circumcision to remove the foreskin while protecting
the glans penis.
Although research suggests that circumcision is generally a safe procedure,
there is concern that some serious device-related complications have occurred.
There have been 105 reports of injuries involving circumcision clamps between July 1996 and January 20001. These have included laceration, hemorrhage,
penile amputation, and urethral damage.
The FDA is providing recommendations below that can help avoid these
Nature of the Problem
Gomco® and Gomco-type Clamps
The use of Gomco® and gomco-type clamps that have been reassembled by users with parts from different manufacturers, or that have bent parts or mismatched components, has led to clamps breaking, slipping, falling off during use, tearing penile tissue or failing to make a tight seal. Please note that although Gomco® and gomco-type clamps may appear to have interchangeable parts, these parts may not always be safely interchanged because they may vary slightly in dimensions.
Mogen® and Mogen-type Clamps
The use of Mogen® and mogen-type clamps that have jaw gap dimensions greater than those in the manufacturer's specifications, or use of clamps
inappropriately sized for patients, has led to patient injuries. In such cases,
the clamp may allow too much tissue to be drawn through the opening of the
device, thus facilitating the removal of an excessive amount of foreskin and in
some cases, a portion of the glans penis.
Before performing a circumcision procedure, examine the clamp to determine
that all parts are available, undamaged, and within the manufacturer’s
Gomco® and Gomco-type clamps:
- If you cannot be certain that a clamp component is part of the original
clamp or if the clamp has stripped threads, a warped or bent base plate, a
bent arm, twisted forks, or a scored or nicked bell, either contact the
device manufacturer to obtain replacement parts2 or discard
- When requesting a replacement part, obtain the assurance of the
manufacturer or supplier that the part ordered is compatible with the other
components of your device. Do not substitute parts from different clamp
- Make sure that you reassemble a clamp from only its own parts. Do
not mix up parts from different clamps, even from the same manufacturer,
unless the manufacturer has assured you that the parts are interchangeable.
- If you choose to mark clamp parts to assure that you correctly reassemble
them, ask the manufacturer about the best way to do this, because some
marking methods may weaken the device or compromise your ability to
Mogen® and Mogen-type clamps:
- Ensure that the clamp being used is appropriate for the patient size. Some
manufacturers have two sizes of clamps, one for adults and the other for
- Periodically measure the gap between the device’s clamping jaws to
ensure that it is within the manufacturer’s specification.3
Using a device with an inappropriate jaw gap could allow the tip of the
penis to be drawn through the clamp with the foreskin and inadvertently
severed or injured.
Reporting Adverse Events to FDA
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user
facilities to report deaths and serious injuries associated with the use of
medical devices. This means that if the use of a Gomco/gomco-type clamp
or a Mogen/mogen-type clamp result in a death or serious injury, you must
report that event. We request that you follow the procedures established by your
facility for such mandatory reporting.
If a circumcision clamp malfunctions, you can report this directly to the
manufacturer. Alternatively, you can report directly to MedWatch, the FDA's
voluntary reporting program. You may submit reports to MedWatch four ways:
online to http://www.accessdata.fda.gov/scripts/medwatch/
by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178, or by mail to MedWatch,
Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
Getting More information
Health professionals with questions regarding this notice and the advice from the FDA, please contact Sherry Purvis-Wynn, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax at 301-594-2968, or by e-mail at firstname.lastname@example.org.
Additionally, a voice mail message may be left at 301-594-0650, and your call
will be returned as soon as possible.