It was reported by a customer that on (b)(6) 2018, a 14-69 malik cystic duct had some residue or substance around the lockbox area.The product was not in contact with the patient.No patient injury or death alleged, and the event did not lead to increase the surgery time.No other clinical information received.Additional information had been requested.
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The device was returned to the manufacturer for physical evaluation, therefore the failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.The returned forceps are new without the original packaging.The product identification markings have been removed/neutralized, per the customer's request.The residue is a result of the compound and buffing material used during the neutralization process.The residue is easily removed with a soft cloth.Manual surgical instruments, unless otherwise noted, are sold non-sterile and require thorough cleaning, disinfecting, and sterilizing prior to use.
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