Catalog Number OR-3036/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device has returned for evaluation.A follow up report will be submitted when the evaluation is complete.
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Event Description
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The account alleges that there was a defect in the packaging resulting in incomplete sterilization of the contents.The defect was identified during preparations for the procedure.No patient contact or injury to report.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint was confirmed.The root cause could not be determined.Damage to the back table cover could have occured during assembly in the cleanroom or at supplier manufacturing site.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
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Search Alerts/Recalls
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