Report confirmed.Evaluation determined that the footed portion was damaged by tool contact.A portion of the foot of the attachment was detached and missing.It was also noted that the internal tube bearing was corroded and the color band was faded.Previous investigation performed under (b)(4) determined that the likely causes are debris in the collet and improper insertion of the tool.The user manual contains the following warnings ¿do not use a legend attachment if any part of the attachment appears to be bent, loose, missing or damaged.Do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff." in addition, ¿insert dissecting tool into motor collet with a slight rotational motion.A tactile and audible click is observed indicating that the dissecting tool is fully seated.¿ we will continue to monitor this complaint type for trends.(b)(4).
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Repair request initiated for device with the report of attachment foot being damaged by tool contact.It was reported that there was no patient or staff impact.Repair request escalated to a product event based on reason for return.On follow up it was confirmed there was no patient or staff impact, however, no additional information was provided.
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