Model Number 14 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
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Event Description
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Event description: (on (b)(6) 2017, during a preparation): a medical staff tried to attach the insert g4550 to a clamp, however; it did not fit.Another package of insert was opened but the medical staff confirmed deformation at the button.Thus the medical staff canceled to use the second one.This event didn't affect the patient.Additional information received via email from distributor april 5, 2017 - the defects for the g-4550 were noticed before the procedure.Procedure performed: unknown.Type of intervention: na.Patient status: no health damage was reported for the patient.
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Manufacturer Narrative
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Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering determined that the male attachment features (buttons) of the insert were damaged, which would affect the unit's ability to attach to the clamp.It is likely that the root cause of the damage observed on the unit was caused by was improper technique during installation of the insert onto the assembly fixture during manufacturing.This can cause damage to the attachment features, as was observed on the event unit.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.
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Search Alerts/Recalls
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