Model Number B8634 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
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Event Description
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Procedure performed: unknown.Suspected faulty product when opened out of sterile pack before use.No further information is known and was not passed on my medical staff to clinical procurement.Additional information received via email from account manager on wednesday 19jun2019: the guide wire had been reversed loaded ( incorrectly by manufacture), the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.Patient status: non.Type of intervention: the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.
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Event Description
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Procedure performed: unknown.Suspected faulty product when opened out of sterile pack before use.No further information is known and was not passed on my medical staff to clinical procurement.Additional information received via email from account manager on wednesday 19jun2019: the guide wire had been reversed loaded ( incorrectly by manufacture), the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.Patient status: non.Type of intervention: the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit and engineering confirmed the tubing had been cut and stripped off the guidewire.Damage was also observed on the core wire.Based on the description of the event and evaluation of the returned unit, it is likely that the unit came into contact with a sharp edge on an instrument, which caused the coating to separate from the unit.
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Search Alerts/Recalls
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