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.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 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 are subjected to a visual inspection and functional test to ensure proper workability.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, the physician used a cook captura biopsy forceps without spike.Per the physician, ¿the main issue now is the forceps, when closing, are snapping and breaking.The forceps are also not releasing the specimen when this happens [subject of this report].One forceps would not close at all when down gastroscope [see related mdr 1037905-2017-00343].Previously to this the outer sheath had come off exposing the internal wiring.This is only occurring on cold biopsy forceps.
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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, a functional test was performed.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device was sent back to the supplier for evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the device determined the returned device was tested for "would not close." during functional testing, it was confirmed that the device would open but would not close when manipulated using the handle.Upon disassembly of the device tip, it was noted that the solder joint was broken.The reported defect was confirmed for the device.The device failure was due to broken solder joint (butt joint).During cook's initial evaluation, misalignment was potentially observed.When the device was sent back to the supplier, the investigator disassembled the device before investigating the cup misalignment observed.Due to the device being disassembled, cup misalignment could not be evaluated by the supplier.During the supplier's investigation a broken solder joint was observed.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 "forceps when closing are snapping/ breaking" and "the forceps not closing" issue experienced by the customer was confirmed and the root cause was determined to be a broken solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.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 forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability.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.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, a functional test was performed.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device was sent back to the supplier for evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the device determined the returned device was tested for "would not close." during functional testing, it was confirmed that the device would open but would not close when manipulated using the handle.Upon disassembly of the device tip, it was noted that the solder joint was broken.The reported defect was confirmed for the device.The device failure was due to broken solder joint (butt joint).During cook's initial evaluation, misalignment was potentially observed.When the device was sent back to the supplier, the investigator disassembled the device before investigating the cup misalignment observed.Due to the device being disassembled, cup misalignment could not be evaluated by the supplier.During the supplier's investigation a broken solder joint was observed.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 "forceps when closing are snapping/ breaking" and "the forceps not closing" issue experienced by the customer was confirmed and the root cause was determined to be a broken solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.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 forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability.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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