Model Number HST III SYSTEM (3.8MM) |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
Event Type
malfunction
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Event Description
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The hospital reported that the hst iii system (3.8mm) front end is too bent to be usable.After the loading was completed, it was found that the plugging umbrella had cracks, replaced the same equipment to complete the surgery.No surgical delay.No harm to the patient.
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Manufacturer Narrative
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Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Manufacturer Narrative
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Trackwise #(b)(4).The lot history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Search Alerts/Recalls
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