Model Number GWH3505R |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 09/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was returned to the olympus (b)(4) and is pending evaluation.The cause of the reported event cannot be determined at this time.If additional information becomes available following device evaluation and investigation, a supplemental report will be filed.
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Event Description
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The service center was informed that during an ureteroscopy (urs) procedure, the hydrophilic tip of the device broken into pieces inside the patient¿s ureter.The guidewire was withdrawn and the surgeon observed a couple of metal wires that were visible at the tip.An additional procedure was scheduled to remove the device fragments.An x-ray was performed to locate the tip; however, the surgeon was unable to retrieve the device fragments.The user facility reported that the device fragments are draining through a stent and only a 3mm fragment was left, which is expected to come out in 2 weeks.It is unknown if the initial intended procedure was completed.The patient is reportedly in good condition.Additionally, the user facility reported no metal torque device was used with this guidewire.The thumb advance introducer was used with the guidewire.The guidewire did not come in contact with a metal tip of any of the other instruments used during the procedure.No excessive force was required to withdraw or introduce the guidewire.
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Manufacturer Narrative
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This supplemental report is being submitted to report the device evaluation results.The customer returned a gwh3505r for evaluation.The device was received in the plastic protective tubing.It was confirmed that the distal end of the device was not returned; the distal end had roughly 2 inches of exposed wire showing.It was also noticed that part of the blue coating on the sheath was rubbing off in a few spots.
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Manufacturer Narrative
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The oem performed a photographic investigation.Based on the defect pictures epflex has come to the following conclusion: the strong detachment of the coating clearly shows that the guide wire was pulled over an edge with a high force.This also caused the polymer tip to detach from the wire.The damage to the product is therefore definitely due to a user error.
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Search Alerts/Recalls
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