Catalog Number LONG-HD |
Device Problems
Contamination (1120); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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During burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to receive several new attachments so i can proactively replace some older ones at this account.Case type: pka.
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Manufacturer Narrative
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Reported event: during burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to receive several new attachments so i can proactively replace some older ones at this account.Case type: pka.Product evaluation and results: no device inspection could be completed as the product was not available for evaluation.Product history review: product history review was not performed as it is an oem product.Complaint history review: a review of complaints in catsweb and trackwise related to p/n long-hd, s/n (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard h3 other text : product was not available for evaluation.
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Event Description
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During burring the surgeon complained of the anspach long attachment getting hot.It was also making an unusually loud noise.The case was able to be completed as normal.After the case, when the end effector was taken apart, there was some black liquid inside the long-hd.Also appeared as if the inner bearing was worn out.Would like to recieve several new attachments so i can proactively replace some older ones at this account.Case type: pka.
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Search Alerts/Recalls
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