Model Number 471093-11 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 02/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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The prograsp forceps instrument has not been returned to intuitive surgical, inc.(isi) for failure analysis investigation.System/instrument logs were unable to be performed due to insufficient information provided.
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Event Description
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It was reported that during a davinci assisted benign hysterectomy surgical procedure, the prograsp forceps instrument broke and was jammed in one position.The instrument was not attached to any tissue inside the patient.The surgeon was unable to straighten the instrument.As a result, the procedure was converted to an open surgery to remove the jammed instrument along with the cannula.It was also reported that a fragment fell into the patient and was retrieved during the same procedure.Following the procedure, the staff tried to assess the damage but could not straighten the instrument to remove it from the cannula; however, the instrument was still jammed. the instrument was inspected prior to use with no issue identified.It was confirmed that the patient did not experience any post-operative complications.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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The prograsp forcep was received for failure analysis.The proximal clevis was dislodged; the dislodged proximal clevis was not attached to the main tube.Additionally, the instrument was found to have a broken main tube at the distal tip.A piece measuring 5.55 mm x 7.60 mm was not returned.
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Search Alerts/Recalls
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