STRYKER ENDOSCOPY-SAN JOSE PINPOINT CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number PC9002 |
Device Problem
Off-Label Use (1494)
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Patient Problems
Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2020 |
Event Type
Death
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
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Event Description
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It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: "none of the products are defective/faulty or were involved at the time of death.Patient died during open colon interposition surgery.Products were placed in the thorax only to illuminate.During the surgery, the light guide cable, lens and camera were used to illuminate deeper into the patient's open thorax (to help the doctors see better).The devices are demo goods from our sales rep.Our sales rep was present during the surgery." probable root cause: according the the customer provided event description, no failure or malfunction was associated with the pinpoint system.The patient death which occurred during the case was a separate issue not related to any of the pinpoint devices.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.H3 other text : 81.
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