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Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = exempt.Investigation ¿ evaluation as reported, the ncircle tipless stone extractor would not open during an unknown procedure.The procedure was complete by using another same typd device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.A document-based investigation was performed including a review of, complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control procedures.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other complaints associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, t _ ntse_ rev1; the ifu does not provide any information related to the reported issue.Based on the available information, no product returned, and the results of the investigation, the cause for this failure cannot be determined at this time.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 to a death or serious injury if a malfunction occurred.
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