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Model Number R1010 |
Device Problems
Break (1069); Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical , inc.Is currently investigating the reported condition.
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Event Description
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Per medwatch received : uf/importer report number - (b)(4).Patient in for loop electrosurgical excision procedure (leep procedure).Patient was grounded with electrode dispersal pad on right abdomen and pad plug was plugged into electrocautery machine.Surgeon asked for electrocautery machine levels to be at 50.When leep radius electrode r1010, lot # 284926 was applied, doctor said it sparked, and asked for levels to be brought down to 45.Cautery was applied again and electrode sparked again and she said, "look at this, it just broke." asked if any pieces were left inside the vaginal canal, she said that "no, it just snapped in half." i gave her a new electrode and lowered levels down to 40 and case progressed without any further issues.Broken leep electrode saved, charge nurse and supervisor notified.Case ended and grounding pad was removed ; no skin changes on abdomen.1216677-2021-00119 radius loop elec box of 5 r1010 (b)(4).
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Event Description
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Per medwatch received : uf/importer report number - (b)(4).Patient in for loop electrosurgical excision procedure (leep procedure).Patient was grounded with electrode dispersal pad on right abdomen and pad plug was plugged into electrocautery machine.Surgeon asked for electrocautery machine levels to be at 50.When leep radius electrode r1010 lot # 284926 was applied, doctor said it sparked, and asked for levels to be brought down to 45.Cautery was applied again and electrode sparked again and she said, "look at this, it just broke." asked if any pieces were left inside the vaginal canal, she said that "no, it just snapped in half." i gave her a new electrode and lowered levels down to 40 and case progressed without any further issues.Broken leep electrode saved, charge nurse and supervisor notified.Case ended and grounding pad was removed ; no skin changes on abdomen.1216677-2021-00119 radius loop elec box of 5 r1010 (b)(4).
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Manufacturer Narrative
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Investigation x-no sample returned x-review dhr *analysis and findings (b)(4).*was the complaint confirmed? no.Distribution history the complaint product was manufactured at csi on 09/04/2020 under work order (b)(4).Manufacturing record review dhr-284926 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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Search Alerts/Recalls
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