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This is 7 of 23 reports.It was reported by a customer that a 100220 mayo scissor 6-3/4 str round blade failed quality control with a suspected bioburden, causing an operating room delay on (b)(6) 2018, for an unspecified procedure.Additional information was received on 06-nov-2018, stating that the sterility of the device was compromised, it was tested for proteins and removed from the field.The surgical case was broken down.The device was not in contact with the patient.No reports of patient injury or death alleged.
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Additional information was received on 27nov2018: an integra site meeting with the customer identified that there was no bioburden as initially reported, however, the issue was rust and corrosion.The jarit instruments were manually washed, put through an ultrasonic bath, and then placed in an autowash with steris prolystica ph neutral detergent.The instruments came out with rust stains.The instruments were rewashed, and the rust dissolved.The instruments were then ran them through the autoclave process, and the instruments came out with rust stains.The client has a known water problem.The final rinse in the washing process is with reverse osmosis (r.O.) water.The r.O.Water system was offline when the incident happened.The system was cleaned but well water in the area is hard with high iron content.This could be a root cause.However, the rust stains only happen with jarit instruments and not with instruments.The client questioned the following: 1.If the surface texture of the jarit instruments, matte, makes it easy for rust originating in the hospital water system to adhere? 2.If the rust is from impurities leaching out of the devices.Jarit instrument suppliers may be using recycled metal with a higher content of impurities.These device suppliers, even if small companies, need to be audited.The device was returned to the manufacturer for physical evaluation.An investigation of the device manufacturing records was conducted.There were no deviations or non-conformances during the manufacturing process.Brown corrosion stains/pits are visible, the cutting edges are damaged, and no preventive maintenance markings are present.Additionally, no bioburden was detected.No manufacturing, workmanship, or material deficiency was identified.Device identifier (b)(4).
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