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Model Number 1806-0041 |
Device Problem
Residue After Decontamination (2325)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
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Event Description
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As reported: "on (b)(6) at the sanatrix nursing home, due to a private gamma 3 intervention, an unpleasant inconvenience occurred; shortly before starting the operation, with the patient already anesthetized on the operating table, the instrumentalist checks the gamma 3 instruments on the sterile serving table, after inserting the guide wire into the curved cannulated awl code 18060041, organic material composed of clots of blood and bone leaked onto the sterile serving table in front of the operators.At this point, sterility having been compromised, it was decided to sterilize everything again, to clean the instrument and postpone the surgery for about 40 minutes (with the patient already under deep anesthesia).".
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Event Description
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As reported: "on 12 may, at the sanatrix nursing home, due to a private gamma 3 intervention, an unpleasant inconvenience occurred; shortly before starting the operation, with the patient already anesthetized on the operating table, the instrumentalist checks the gamma 3 instruments on the sterile serving table, after inserting the guide wire into the curved cannulated awl code 18060041, organic material composed of clots of blood and bone leaked onto the sterile serving table in front of the operators.At this point, sterility having been compromised, it was decided to sterilize everything again, to clean the instrument and postpone the surgery for about 40 minutes (with the patient already under deep anesthesia).".
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Manufacturer Narrative
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The device was not returned for evaluation and no other evidences were provided.Nevertheless as the event is rated as confirmed a local capa was opened to address this service related event.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on the provided information it can be concluded that this complaint is not product related, the information indicates that the reprocessing of the awl was not properly carried out.Therefore a local capa was opened in italy to address this consignment related event.If more information is provided, the case will be reassessed.
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Search Alerts/Recalls
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