Model Number E1562 |
Device Problem
Break (1069)
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Patient Problem
Blood Loss (2597)
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Event Date 03/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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Event Description
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The customer reported that the loop electrode snapped at edge.There was a fair amount of tissue loss.Additionally, there was more than 500cc of bleeding but no transfusion was needed.The area was sutured.The patient is stable.
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Manufacturer Narrative
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One e1562 loop electrode was received for evaluation.Visual inspection found the wire loop to have broken.The customer reported a forcefxc generator with coag output at 70 was used during the procedure.According to the instructions for use, covidien recommends a maximum power setting of 55w cut for this type of electrode.This type of electrode should never be used in the coagulation mode.The investigation identified the root cause of the reported event to be user misuse by exceeding recommended power setting and using the device in the coagulation mode.The ifu states loop electrodes are not designed for use in the coagulation mode.Do not activate the generator in coag while using a loop electrode.Loop breakage may result.Exceeding maximum power setting may result in patient injury or product damage.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported that the loop electrode snapped at edge during a leep procedure.A forcefxc generator with coag output at 70.There was a fair amount of tissue loss.Additionally, there was more than 500 cc of bleeding but no transfusion was needed.The area was sutured.The patient is stable.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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