Catalog Number 004551004 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been received for evaluation by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
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Event Description
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Customer complaint alleges "the handles were broken at the junction point in the package." there was no report of patient involvement.It is unclear if the alleged defect reported was found in the clinical setting.
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Manufacturer Narrative
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(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured as per release specification.The sample was returned for evaluation.A visual exam was performed and no defects were observed.The light guide was not broken as reported in the complaint.The device was found to be fully functional.The complaint could not be confirmed.
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Event Description
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Customer complaint alleges "the handles were broken at the junction point in the package." there was no report of patient involvement.It is unclear if the alleged defect reported was found in the clinical setting.
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Search Alerts/Recalls
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