Occupation: other healthcare professional appropriate term/code was not available was used for this event.The preferred term for this event is: product does not function as anticipated.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The size of tissue sample or biopsy to be excised can be controlled by how the user handles the forceps.If excessive pressure was applied during advancement into the tissue or during handle manipulation, this could have contributed to the reported observation.The instructions for use (ifu) direct the user to, ¿advance forceps to biopsy or retrieval site, then open cups and advance into tissue to be biopsied or objected to be retrieved.Using slight pressure on handle, close forceps around tissue or object.Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site.¿ prior to distribution, all captura pro biopsy forceps are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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During multiple biopsy procedures, physicians have used an unknown number of cook captura pro¿ biopsy forceps with spike.Multiple physicians feel the forceps are biting too deep and too big.This is a general complaint.The area sales representative reported two (2) possible reference part numbers (rpn), bf-2.4sl-230sp-20 or bf-2.4sl-230sp-40.No section of the devices remained inside the patients' bodies.The patients did not require any additional procedures due to these occurrences.According to the initial reporter, the patients did not experience any adverse effects due to these occurrences.
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