Clamp involved was not returned for evaluation.Pictures of clamp involved do not show the size or a g stamped on the bell/stud.Hospital confirmed that there was no marking on the bell/stud.The other three parts of the clamp had proper gomco markings on them.This indicates the bell/stud was probably from a different manufacturer.Parts from clamps of different manufacturers may have been mixed during the cleaning process.We have no control over dimensions of copy cat parts made by other manufacturers.The clamp instruction manual states the following: warnings: this clamp must never be used if component parts are damaged, missing, clearly worn, or the assembled device does not perform as described.Prior to indicating the surgical procedure, you must insure that expected clamping functionals been properly achieved.Use only components parts manufactured by "gomco" when assembling this device.Important: some bleeding may occur and/or some sutures may be required depending on the prescribed surgical technique.
|
It was reported that a male infant undergoing circumcision with a gomco 1.1 cm clap.According to physician, the device did not appear to crimp down enough to seal the foreskin, causing more bleeding than normal.Added pressure to site and monitored to ensure hemostasis.Infant did not have a prolonged stay and was discharged without complications.
|