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Catalog Number HARH36 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.Additional information was requested and the following was obtained: the white tissue pad felt down during the device using.
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Event Description
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It was reported that during a total hysterectomy and anencetomy by ul procedure, in the course of the surgery with the coagulating scissors harmonic, it was necessary to clean the tip of the clamp and when cleaning the white part of the clamp was loosened and thus it was not possible to use the clamp until the end of surgery, being necessary to open another clamp to continue the surgery.The patient was fine when she leave the surgery; she went to the room as routine.There were no adverse consequences for the patient.
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Manufacturer Narrative
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(b)(4).Batch # l9362z.The analysis results found that the device was received with the tissue pad detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test hand piece and a gen11 and the device did activate during functional testing.The device was disassembled to inspect the internal components and no anomalies were found.Based on the condition of the tissue pad, a probable cause of this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.The batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.
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Search Alerts/Recalls
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