Investigation: the instrument is in a new condition, no deviation can be found with the naked eye.Vigilance investigator carried out the pictorial documentation visually (panasonic).No deviation could be found at the mint instrument, neither during functional test, nor during visual inspection.Only small scratches can be found at the tip of the blades, most likely caused by vibrations in a closed state.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: the instrument is according to the specifications, no deviations can be found at the provided instruments.Furthermore, the contact person at the hospital confirmed that the retractor was not the cause of the patient's death but the gunshot-injury.No capa is necessary.
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It was reported that the rib spreader failed intraoperatively.During a trauma case (gunshot wound to the chest) when preparing to use the finochietto retractor (rib spreader) it was noticed the retractor was assembled incorrectly, making it unusable.The retractor was disassembled before sterilization, and was noticed when the sterile tray was opened.The rotation knob was on the patient side of the retractor.As a result the surgeon needed to crack the patient's sternum.It was reported the patient died due to the fatal gunshot wound and not because of the retractor.Patient information was not provided.
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