Model Number 470207-10 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has received the tenaculum forceps instrument for evaluation.As of the date of this report, the failure analysis investigation has not yet been completed.
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Event Description
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It was reported that during a da vinci-assisted myomectomy gynecological surgical procedure, the tenaculum forceps instrument failed while in patient.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the tenaculum forceps instrument didn¿t have any broken/loose cables visible at the instrument wrist when introducing the instrument into the patient.The damage was identified during the procedure on (b)(6) 2024.There was no report of fragments falling into the patient body.The instrument wires could have poked the patient.
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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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Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tenaculum forceps instrument was analyzed and reported failure was confirmed.After the visual inspection, the instrument was found to have a broken grip cable at the grip hub causing instrument fail as reported by the costumer.Cable was found to be fully broken.The broken cable strands stuck out at the wrist.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.
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Search Alerts/Recalls
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