It is unknown whether the reported device was a medtronic product.The product was unavailable for return.Therefore an evaluation of device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.The instructions for use that accompany the medtronic clip gun kit specify that the clip gun kit containing a clip gun, pre-loaded magazines with scalp clips, and removal forceps is a single-use disposable kit.(b)(4).
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It was reported to medtronic neurosurgery that the patient was admitted to the hospital for removal of two melanoma metastases to the right occipital and the right parietal lobes of his brain.Reportedly, the patient had 2 craniotomies, and during both of these operations raney clips were used to compress the layers of the scalp in order to stop it from bleeding and to keep the scalp out of the surgical area.According to the report, the patient returned to surgery for a craniotomy and a wound irrigation and drainage with removal of the bone flap.The neurosurgeon's note stated there were signs of infection so he took cultures and then irrigated the wound with two different antibiotic solutions.It was reported that during the irrigation, a green raney clip was found floating in the irrigant and because clips had not been applied to the skin edge during the current wound washout, it was possible that the clip was remnant from the prior operation, and it was removed.Reportedly, a drain was placed in the surgical area to drain cerebral spinal fluid and residual infection.
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