Catalog Number 0250070620 |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that a piece of the piercing rubber fell inside the patient.Please note that the piece was removed and the procedure was completed successfully.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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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: rubber piece falling inside the patient probable root cause: material/design error manufacturing/assembly/ service error excessive user force severe shipping conditions disposable tip rubbing against product user error the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Event Description
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It was reported that a piece of the piercing rubber fell inside the patient.Please note that the piece was removed and the procedure was completed successfully.
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Search Alerts/Recalls
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