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Investigation evaluation: the user provided a photo of the area where the biopsy was taken.The photo provided shows the area is bleeding.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps would take a bite of the simulated tissue as expected.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.The investigation is on-going because the device is being sent to the supplier.A follow-up emdr will be provided within 30 days of submission of this report.
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During a biopsy procedure, the physician used a cook captura pro biopsy forceps with spike.The customer says it [forceps] was tearing tissue.[the user] took a bite [sample] in the cecum and tore tissue during this process.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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During a biopsy procedure, the physician used a cook captura pro biopsy forceps with spike.The customer says it [forceps] was tearing tissue.[the user] took a bite [sample] in the cecum and tore tissue during this process.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation evaluation: the user provided a photo of the area where the biopsy was taken.The photo provided shows the area is bleedingour laboratory evaluation of the product said to be involved could not confirm the report as it was described.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps would take a bite of the simulated tissue as expected.The device was sent back to the supplier for further evaluation.The supplier provided the following in their response letter: one device from the reported event was returned in a zip type bag with proof of decontamination.Visual evaluation: the device (bf-2.4sl-230sp-40, lot w4131888) was visually evaluated.The device has no signs of damage.The finished device passed the final quality check (fqc) checklist.Functional evaluation: the device was functionally evaluated.To simulate the worst case tortuous path the device was coiled in three (3), eight (8) inch loops.The device operated properly when the handle was manipulated.The device opened and closed and took a clean bite of simulated tissue.The reported defect for "tearing tissue" was not confirmed.The device functioned as intended.The device history records were reviewed.No relevant defects were noted in the manufacturing and/or fqc checklist records.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the supplier provided the following: the reported issue 'forcep tore tissue' was not confirmed.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 the forceps into the tissue at the desired biopsy site.Then the user is instructed to close the forceps around the tissue while using slight pressure on the handle.The user is instructed to maintain gentle handle pressure to keep the cups closed and gently withdraw the forceps from the site.Ifu warning states: "these single-use forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients.Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place." the ifu lists potential complications as: "those associated with gastrointestinal endoscopy include but are not limited to: perforation, bleeding or hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all captura pro disposable biopsy forceps are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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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