Catalog Number 004551003 |
Device Problems
Material Fragmentation (1261); Device Damaged Prior to Use (2284)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2018 |
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 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 "fragments of the blade (plastic part) are already in the unopened packaging.The blades cannot be put on the handles in this way." alleged defect reported identified prior to patient use.There was no report of patient or user injury.There was no report of patient involvement.
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Manufacturer Narrative
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Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the base of the light guide is broken.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
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Event Description
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Customer complaint alleges "fragments of the blade (plastic part) are already in the unopened packaging.The blades cannot be put on the handles in this way." alleged defect reported identified prior to patient use.There was no report of patient or user injury.There was no report of patient involvement.
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Search Alerts/Recalls
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