Catalog Number 0250080767 |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the device broke during the procedure.Per additional information received, an x-ray was performed and came back negative the procedure was completed successfully.
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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: jaw broke.Probable root cause: poor autoclave reliability.Shear pin failure in handle.Use error.Damage during manufacturing/ servicing.The reported failure mode will be monitored for future re-occurrence.Manufacture date is not known.
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Event Description
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It was reported that the device broke during the procedure.Per additional information received, an x-ray was performed and came back negative the procedure was completed successfully.
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Search Alerts/Recalls
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