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, an indigo system separator 8 (sep8) slipped off the table and became contaminated.The sep8 slipped off the table prior to use and therefore, the sep8 was not used in the procedure.The procedure was successfully completed using a new indigo system separator 8 (sep8).
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