Model Number LUCAS |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Stryker performed a clinical review regarding the reported issue.There is insufficient information to determine if the device caused or contributed to the reported outcome.
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Event Description
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The customer contacted stryker to report that their device was involved in six cases of internal thoracic artery injuries during use.
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Manufacturer Narrative
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Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted stryker to report that their device was involved in six cases of internal thoracic artery injuries during use.
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Search Alerts/Recalls
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