The procedure was a left groin discectomy that was done on the (b)(6) 2018, the device is a ligaclip, code mcm20.The device was sticking and miss firing, the clips were not closing.A new device was opened to complete the procedure and there was no impact on the patient.I was not in the procedure when this happened.
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(b)(4).Batch # r93p2r.The analysis results found that the mcm20 device was received with no damage in the external components.In an attempt to replicate the reported incident, the device was cycled and one partially clip was formed due to an anti backup failure.The remaining 6 clips were fed and formed as intended.Finally, the instrument locked out.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the hoop spring and the anti-backup lever were found to be out of its intended position.No conclusion could be reached as to what may have caused the reported incident.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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