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Model Number 52969 |
Device Problems
Device Operates Differently Than Expected (2913); Temperature Problem (3022)
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Patient Problems
Pain (1994); Partial thickness (Second Degree) Burn (2694)
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Event Date 05/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).
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Event Description
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Summary surgery/procedure event (b)(6).Incident description: leep procedure, grounding pad located on upper left thigh, plugged into machine, when the physician was using cutting feature at 46w power there were no issues, and then unit was switched over to cautery tool, unit power was set at 36w, halfway through the procedure when using ball to cauterize, patient jumped and claimed of pain, insulated speculum in place, dr withdrew cauterize tool and observed 2 burned spots on sides of procedure area.Procedure was immediately halted and different methods were used to treat patient nature of injury - burn.Location of injury on body - vagina.Harm - temporary, intervention needed.(b)(4).
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Manufacturer Narrative
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Ref e-complaint-(b)(4).Please find attached the leep 1000 final mdr submission package, regarding all initial mdr's, and retro review initial mdr's filed for reports of intermittent function during use.The documents included in this package are as follows: · leep system investigation summary · leep 1000 tech bulletin cover letter · tech service bulletin 12151 · project #(b)(4)- leep system 1000 root cause.This concludes coopersurgical' s root cause investigation.Coopersurgical, inc.Will continue to monitor the complaint condition for tending and safety.
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Event Description
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Summarysurgery/procedure event (b)(4).Incident description: leep procedure, grounding pad located on upper left thigh, plugged into machine, when the physician was using cutting feature at 46w power there were no issues, and then unit was switched over to cautery tool, unit power was set at 36w, halfway through the procedure when using ball to cauterize, patient jumped and claimed of pain, insulated speculum in place, dr withdrew cauterize tool and observed 2 burned spots on sides of procedure area.Procedure was immediately halted and different methods were used to treat patient.Nature of injury - burn, location of injury on body - vagina, harm - temporary, intervention needed.Reference e-complaint (b)(4).
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Search Alerts/Recalls
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