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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.The report could not be confirmed.There were no nonconformances documented for the lot number said to be involved.A discrepancy or anomaly was not observed with the product that was released for distribution.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 instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.There were no nonconformances documented 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.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.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.The report could not be confirmed.There were no nonconformances documented for the lot number said to be involved.A discrepancy or anomaly was not observed with the product that was released for distribution.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 instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.There were no nonconformances documented 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.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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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the handle was manipulated and the cups will open and close as intended.While the cups are in the open position, the link wires on the forceps cups appear to be bent.When the cups are in the closed position, the forceps cups are misaligned.While observing the cups for misalignment, it was noted that one of the cups is pointing inward while in the closed position.The cup that is pointing inward appears as if it could be twisted.When the cups are in the open position, the link wires are bent outward from the forceps cups housing.The device was not advanced through an endoscope due to the misalignment of the device.The device was sent to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.During a functional evaluation of the returned device, the device was tested for "would not open or close." during functional testing, with the device coiled in two (2), eight (8) inch loops, it was confirmed that the device operated properly when the handle was manipulated.The device opens and closes as intended but requires additional exertion.A clicking sound was detected immediately prior to the cup assembly opening.No clicking sound was detected when the cup assembly was closed.The link wires and cup assembly were also evaluated.The cup assembly was found to be bent, stemming from the end of the sheath.Upon opening the cup assembly, the device link wires were detected to be bent on one side.The device was then disassembled to evaluate the solder connection.The connection was found to be intact.Inadequate functionality and misaligned cups are a result of the bent assembly and link wires.The root cause of the bent assembly and link wires is unknown.The device history records were reviewed and found to be manufactured in october 2017.Relevant defects were noted in the manufacturing and or final quality control checklist records.There were no nonconformances documented for the lot number said to be involved.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 "mechanism of open and close fails" was evaluated.Although the findings of the evaluation determined that the device does open and close; it does not operate freely without hesitation.The bent link wires were the cause of the inadequate functionality and misalignment of the cups.The assignable cause of the bent link wires is unknown.All devices receive a 100% inspection prior to release and shipment.The instructions for use includes the following to ensure proper use of the device: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.There were no nonconformances documented 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.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.Our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the handle was manipulated and the cups will open and close as intended.While the cups are in the open position, the link wires on the forceps cups appear to be bent.When the cups are in the closed position, the forceps cups are misaligned.While observing the cups for misalignment, it was noted that one of the cups is pointing inward while in the closed position.The cup that is pointing inward appears as if it could be twisted.When the cups are in the open position, the link wires are bent outward from the forceps cups housing.The device was not advanced through an endoscope due to the misalignment of the device.The device was sent to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.During a functional evaluation of the returned device, the device was tested for "would not open or close." during functional testing, with the device coiled in two (2), eight (8) inch loops, it was confirmed that the device operated properly when the handle was manipulated.The device opens and closes as intended but requires additional exertion.A clicking sound was detected immediately prior to the cup assembly opening.No clicking sound was detected when the cup assembly was closed.The link wires and cup assembly were also evaluated.The cup assembly was found to be bent, stemming from the end of the sheath.Upon opening the cup assembly, the device link wires were detected to be bent on one side.The device was then disassembled to evaluate the solder connection.The connection was found to be intact.Inadequate functionality and misaligned cups are a result of the bent assembly and link wires.The root cause of the bent assembly and link wires is unknown.The device history records were reviewed and found to be manufactured in october 2017.Relevant defects were noted in the manufacturing and or final quality control checklist records.There were no nonconformances documented for the lot number said to be involved.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 "mechanism of open and close fails" was evaluated.Although the findings of the evaluation determined that the device does open and close; it does not operate freely without hesitation.The bent link wires were the cause of the inadequate functionality and misalignment of the cups.The assignable cause of the bent link wires is unknown.All devices receive a 100% inspection prior to release and shipment.The instructions for use includes the following to ensure proper use of the device: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.There were no nonconformances documented 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.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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