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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.Three devices were received for evaluation.Device #1: during the evaluation of the returned device, the device was functionally tested.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 by manipulating the handle, but they were unsuccessful.The forceps cups were closed manually.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.Device #2: during the evaluation of the returned device, the device was functionally tested.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 by manipulating the handle, but they were unsuccessful.The forceps cups were closed manually.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.Device #3: during the evaluation of the returned device, a functional test was performed.When the handle was manipulated the forceps cups would not open or close, but the handle moved freely.During a visual inspection of the handle, it was observed that the handle drive wire has separated from the handle spool.During the evaluation a pair of tweezers was used to manipulate the drive wire and the cups would open and close as intended.The separation between the handle spool and the drive wire is causing the cups not to open and close.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 drive wire was manipulated by using the tweezers and the device would open and close as intended.All three devices were sent back to the supplier.Investigation conclusion: the product was returned to the approved supplier for evaluation and the investigation is ongoing.Once additional information has been received a follow-up emdr report will be provided.
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.Three devices were received for evaluation.Device one (1): during the evaluation of the returned device, the device was functionally tested.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 by manipulating the handle, but they were unsuccessful.The forceps cups were closed manually.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.Device two (2): during the evaluation of the returned device, the device was functionally tested.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 by manipulating the handle, but they were unsuccessful.The forceps cups were closed manually.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.Device three (3): during the evaluation of the returned device, the device was functionally tested.When handle was manipulated the forceps cups would not open or close, but the handle moved freely.During a visual inspection of the handle, it was observed that the handle drive wire has separated from the handle spool.During the evaluation a pair of tweezers was used to manipulate the drive wire and the cups would open and close as intended.The separation between the handle spool and the drive wire is causing the cups not open and close.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 drive wire was manipulated by using the tweezers and the device would open and close as intended.All three devices were sent back to the supplier.The supplier provided the following evaluation: device one (1): for the returned device, the device was tested for "would not open or close." during functional testing, with the device coiled in two (2) 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device has a butt joint that has broken at the solder connection.The reported defect of "would not close" was the only confirmed defect.Device two (2): for the returned device, the device was tested for "would not open or close." during functional testing, with the device coiled in three two (2) 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device has a butt joint that has broken at the solder connection.The reported defect of "would not close" was the only confirmed defect.Device three (3): for the returned device, the device was tested for "would not open or close." during functional testing, with the device coiled in three two (2) 8" loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device opens but does not close.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was intact.Upon additional investigation, it was noted that the push rod and upper and lower spool assembly were damaged and no longer in contact.The reported defect of "would not close" was the only confirmed defect.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 customer experienced issue of "could not open and close" was confirmed; the devices open but do not close.Two of the devices have a butt joint that has broken at the solder connection.The root cause is a butt joint with a broken control wire / link wire solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.The third device was found to have damage at the push rod and upper and lower spool assembly, and these were no longer in contact.The evaluation was unable to determine how or when this damage occurred.Awareness training will be provided to the production operators and final quality control inspectors for this defect.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." instructions for use states: "using slight pressure on handle, close forceps around tissue or object.Note: it is no necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope.Prior to distribution, all captura biopsy forceps without spike 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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