STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Model Number 0375704500 |
Device Problems
Insufficient Cooling (1130); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burn(s) (1757); Burn, Thermal (2530)
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Event Date 11/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the patient was burned.
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Manufacturer Narrative
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Alleged failure: shaver over heating burned salesforce case number (b)(4).Harm: burned pt.Delay: 5m.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be 1) excessive force applied to the cutter/burr by the user with poor or no suction during use.(excessive force may cause friction due to bur shaft assembly and housing assembly interaction.) (2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.(4) additionally, during arthroscopic procedures, it is common to use an rf energy wand.Inherent to use of an rf probe is the risk of potential superficial patient burns due to the heat generated from the rf output.Therefore use of the rf probe can also be considered a possible root cause as well.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Event Description
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It was reported that the patient was burned.
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Search Alerts/Recalls
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