Catalog Number UNK_END |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/15/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the broken pieces of the sheath and electrode remained inside the patient.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known.Alleged failure: the resectoscope has broken inside of the patient; the sheath and electrode has split from the handle.Probable root cause: user excessive force or torque.Manufacturing/assembly error.User error in not properly inspecting unit prior to use.Use of incompatible instrumentation/hardware.Improper cleaning/sterilization.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the broken pieces of the sheath and electrode remained inside the patient.
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Search Alerts/Recalls
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