Catalog Number 07.02077.001 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2019-00554.
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Event Description
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It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off.The tips were not able to be retrieved and were retained by the patient.There were no reported surgical delays or additional patient impacts reported.This is report two of two.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off.The tips were not able to be retrieved and were retained by the patient.There were no reported surgical delays or additional patient impacts reported.This is report two of two.
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Event Description
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It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off.The tips were not able to be retrieved and were retained by the patient.There were no reported surgical delays or additional patient impacts reported.This is report two of two.
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Manufacturer Narrative
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Additional information in b4, d4 (udi), g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.The returned device was evaluated.Visual inspection revealed the tip has fractured off.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.A definitive root cause cannot be determined.
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Search Alerts/Recalls
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