Catalog Number CAT02855 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the tip broke and remained inside the patient.
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Event Description
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It was reported that the tip broke and remained inside the patient.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip broke off.Probable root cause: design: instrument tip not designed for insertion into cannula.Improper raw material selection.Assembly design not strong enough to withstand insertion effort.Manufacturing.Incorrect raw materials used.Instrument not manufactured to specification.Instrument not assembled properly.Application.Excessive force.User attempts to insert into cannula which already supports access of other.Instruments to the joint space.User attempts to insert device without use of a cannula.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Search Alerts/Recalls
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