Model Number 173016 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during the procedure, the needle broke inside the patient.The doctor took off the needle.There was patient injury but no medical intervention was required.
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Manufacturer Narrative
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Evaluation summary post market vigilance (pmv) led an evaluation of one device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter during a total laparoscopic hysterectomy procedure, the needle broke inside the patient.The doctor took off the needle.There was no patient injury.
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Search Alerts/Recalls
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