Investigation/evaluation: a review of documentation including the complaint history, instructions for use (ifu), quality control and drawing of the device was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed.However, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record could not be completed due to unknown lot information.A search was completed for all lots on the reported rpn sold to the customer during the time frame 3 years prior to the incident (01jan2016-13jun019), however a manageable suspected lot list could not be produced.A search for complaints reported on these lots found no additional complaints reported from the field.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.Cook will continue to monitor for similar complaints.The appropriate personnel have been notified.Per quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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