Model Number 78-92002 |
Device Problems
Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
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Event Description
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It was reported that during the case, the surgeon needed to make adjustments for the devices to fit.
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Manufacturer Narrative
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Corrected data: d9/h3, original surgery delay time reported was 120 minutes and was later reported as a delay of 70 minutes.H3 other text : device not available.
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Event Description
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It was reported that during the case, the surgeon needed to make adjustments for the devices to fit.
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Search Alerts/Recalls
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