Catalog Number 702496 |
Device Problems
Contamination (1120); Contamination /Decontamination Problem (2895)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "it was reported that when preparation of surgery to remove asniss after bone fusion, the foreign matter was confirmed on the extractor." procedure was completed successfully with no adverse consequences or surgical delay reported.
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Event Description
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As reported: "it was reported that when preparation of surgery to remove asniss after bone fusion, the foreign matter was confirmed on the extractor." procedure was completed successfully with no adverse consequences or surgical delay reported.
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Manufacturer Narrative
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The reported device was not returned for evaluation.Only debris of skin / blood (the reported foreign matter) were provided.Based on investigation, the root cause was attributed to be maintenance related.The failure was caused by possible inadequate cleaning at the hospital.Nevertheless more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the returned debris is merely parts of skin and dry blood, no metal debris can be found from either the asnis extractor nor from the removed screw.As it was mentioned that this was reported during preparation of the surgery, we could only determine that these depositions were either left on the instrument due to the fact that it was not properly cleaned or it was from the patient.However no further information could be obtained.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.Disposition unknown.
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Search Alerts/Recalls
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