Catalog Number MSZ-M295 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event as follows: each sizer is supplied sterile in a sealed, double package.Sterility of the sizer is maintained only if the packages, including the package seals, are intact.Do not use the product if the packages or seals have been damaged.Do not use damaged or contaminated re-sterilizable sizers.
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Event Description
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Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it" and that the "sizer had a cut in it like a paper cut but it was a piece of plastic or silicone".The device was washed and used.
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Manufacturer Narrative
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A review of the device history record has been initiated.If any new, changed, or corrected information is noted, a supplemental medwatch will be submitted.Lab analysis results: visual analysis of the returned device identified: no unusual conditions and no particles as described in the original report.Visual analysis also identified weight to the spec.Additional analysis was performed which identified: bubbles in gel after the autoclave cycle.Based on the device analysis the final assessment is: no issues found related with the manufacturing process, no particles on the device were observed and for this reason it is not possible confirm the reported complaint (foreign material on implant).The device was found to be intact and functional.
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Event Description
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Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it" and that the ¿sizer had a cut in it like a paper cut but it was a piece of plastic or silicone".The device was washed and used.
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Search Alerts/Recalls
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