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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation
as reported, upon opening the package ¿during in vitro testing¿ prior to an unspecified procedure, the user found one ncircle tipless stone extractor¿s basket to be ¿damaged¿ and ¿broken¿ (reported under patient identifier (b)(6)).A second ncircle tipless stone extractor from the same lot number was opened and the user noted, ¿the red conjunction area broken and green wire has no contraction force¿ (reported under patient identifier (b)(6)).A third new unspecified device was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, product specifications, and instructions for use, as well as a visual inspection of the returned device were conducted during the investigation.One device was returned to cook in an open package with label for examination.Upon visual inspection, residue was found on the unidex handle.After disassembling the male leur lock adaptor, the broken tipped catheter was found.Additionally, a document-based investigation evaluation was performed.A review of the device master record concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr showed no discrepancies related to the reported failure mode.A complaint history search identified two other related events from the same customer.There is no evidence of a common manufacturing-related cause for these complaints.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The instructions for use was reviewed and did not contain any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, a potential root cause for this event could not be established.The devices are functional tested multiple times during manufacturing and quality control checks.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 toa death or serious injury if a malfunction occurred.
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