Circumcision clamps might cause injury
The Food and Drug Administration (FDA) has issued a letter to physicians warning them of the potential for injury with some circumcision clamps. Risk managers are advised to warn clinicians about the situation, which could lead to serious injury and litigation.
The FDA sent a letter to physicians advising them not to substitute or interchange Gomco- type clamp components from other clamps, regardless of the manufacturer, and to ensure Mogen-type clamps fit the patient properly. "Although research suggests that circumcision is generally a safe procedure, we are concerned that some serious device-related complications have occurred," the FDA says in the letter. Between July 1996 and January 2001, the agency has received 105 "reports of injuries involving circumcision clamps," including "laceration, hemorrhage, penile amputation, and urethral damage."
The FDA says the danger comes from using Gomco and Gomco-type clamps that have been reassembled by users with parts from different manufacturers or that have bent parts or mismatched components. Those tools can break, slip, and fall off during use, tearing penile tissue or failing to make a tight seal. "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," the FDA explains.
In addition, the FDA warns that if the clamp has stripped threads, a warped or bent base plate, a bent arm, twisted forks, or a scored or nicked bell, the user should either contact the device manufacturer to obtain replacement parts or discard the clamp.
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