The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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During preparation for a thrombectomy procedure, the indigo system separator d (sepd) was inadvertently dropped by scrub technologist upon removal from the packaging.The reported issue was found prior to use and therefore, the sepd was not used in the procedure.The procedure was completed without using more devices.
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