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The reported event was inconclusive.No sample was returned for evaluation and the root cause for the reported failure was unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the needle adapters, stylets and lead glass are the only parts of the quicklink¿ loader that are serviceable by the customer.For more extensive repair or loader replacement, contact bard ® customer service at (800) 977-6733.Indications the quicklink¿ delivery system is indicated for use with sourcelink ® connectors, spacers and brachytherapy seeds in the assembly of seed trains of variable lengths and predetermined spacing between the seeds for use in brachytherapy procedures.Sourcelink ® connectors are indicated for use in seed spacing and linking in brachytherapy procedures.The biospacer¿ seeding spacer is for use in seed approximation in brachytherapy procedures.Contraindications sourcelink ® connectors, being absorbable, should not be used where permanent spacing or linking is required.The biospacer¿ seeding spacer, being absorbable, should not be used where extended approximation of tissue is required.Adverse reactions adverse side effects associated with the use of sourcelink ® connectors and biospacer¿ seeding spacers include: minimal acute inflammatory tissue reaction, calculus formation in urinary and biliary tracts in the event of prolonged contact with salt solutions such as urine and bile, and transitory local irritation.How supplied the quicklink¿ delivery system loaded cartridges and components are supplied sterile.The cartridges are indicated for single use only.The quicklink¿ delivery system loader is supplied non-sterile and must be sterilized in an autoclave before use.Features the quicklink¿ delivery system comes equipped with the following features: quicklink¿ cartridges the quicklink¿ cartridges are constructed of radiation-resistant polycarbonate, and hold a maximum of 20 components.The cartridges are marked with a descriptive icon and scale to indicate the identity and approximate quantity of the contained component, as well as provide a visual key for insertion into the loader carriage.Carriage the carriage is designed to hold the quicklink¿ cartridges containing seeds, spacers, and sourcelink ® connectors.Each slot in the carriage is keyed to a specific cartridge to prevent mix-ups.The carriage may be moved front to back to align the desired component cartridge with the dispensing indicator, or to allow compression and ejection of a seed train.The carriage is also equipped with a quick-release button to allow for carriage removal and inspection.Assembly base and ruler the assembly base is designed to provide a track for the compression of the seeds and sourcelink ® connectors.The ruler provides a means for verifying that the desired train configuration is obtained prior to delivery into the needle.Dispense button the dispense button transfers one component from the indicated cartridge to the assembly track when pressed.Lead glass door this shielding door is designed to provide radiation protection for the user while allowing for visual inspection of the seed train in the assembly track.The door is automatically latched closed, and may be opened by pressing the door release button on the rear of the assembly base.Compression slide handle the compression slide is designed to deliver the necessary stylet force for compression of the seeds and the sourcelink ® connectors into a seed train.The compression slide is factory adjusted to ensure that the proper compressive force is delivered every time.The compression slide is fitted with two support doors to minimize buckling of the stylet during compression.Gate button the gate button is designed to control the gate at the end of the assembly track which is the base for compression of sourcelink ® connectors and seeds.The gate will be closed in normal (up) position to allow for compression.When depressed, the gate will open and allow the seed train to be dispensed through the needle adapter.Needle adapter stainless steel adapters are provided for the attachment of implant needles to the quicklink¿ delivery system.They are designed in 4 different styles to fit all commercially available implant needles.Removable stylet the stylet is designed to compress the seeds and sourcelink ® connectors into a seed train and has been equipped with a luer-lock fitting for quick and easy replacement.Warnings and precautions warning: potential calculus formation with absorbable materials as with any foreign body, prolonged contact of synthetic absorbable material, including sourcelink ® connectors and biospacer¿ seeding spacers, with salt solutions, such as those found in the biliary or urinary tracts, may result in calculus formation.Warning: potential biohazard after use, the quicklink¿ delivery system components may become biohazardous.Handle per accepted medical practice and within applicable laws and regulations.The quicklink¿ delivery system loader is reusable, and the loader components must be thoroughly cleaned and sterilized prior to use and between uses.Warning: radioactive materials / lead components the quicklink¿ delivery system components and the contained brachytherapy seeds should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclide brachytherapy sources and whose training and experience have been approved by the appropriate authorities authorized to license the use of radioactive materials.Use appropriate radiation safety protection practices when working with the quicklink¿ delivery system components that contain radioactive materials.Initiate radiation surveys on the quicklink¿ delivery system components at the completion of the brachytherapy procedure to ensure complete removal of radioactive materials.The shielding glass contains lead, and must be disposed of according to local regulations.Quicklink¿ delivery system manual radionuclide applicator system model #: 70310qca1 manufacturer bard brachytherapy, inc.Carol stream, il 60188 usa (800) 977-6733 caution: storage requirements are temperature dependent extra care should be taken to avoid exposing the quicklink¿ cartridges containing bioabsorbable sourcelink® components to excessive heat or moisture.Store unopened packages at room temperature.Discard open, unused cartridges, sourcelink® connectors, and biospacer¿ seeding spacers.Do not store bioabsorbable components at temperatures that exceed 40°c.Caution: elevated temperatures following loader steam sterilization after sterilization, allow the quicklink¿ delivery system loader components to cool to room temperature prior to use.Caution: avoid damaging the system or using damaged materials never use visibly damaged, bent or broken quicklink¿ delivery system loaders, cartridges or components.This may cause system damage or jamming.Do not force cartridges into the carriage slots.The slots are keyed to accept the appropriate cartridges, and minimal effort is required to properly seat the cartridges.When handling this or any other synthetic absorbable material, care should be taken to prevent any damage to the material.Avoid crushing or crimping damage to the cup ends caused by the application of forceps or tweezers.Ensure the needle adapter and stylet are finger-tight.Do not make any other adjustments to the quicklink¿ delivery system.Do not tamper with the mechanisms that reside beneath the carriage when removing the carriage from the loader.These components are aligned to rigid specifications, and must be handled carefully to maintain proper loader functionality.In the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.Do not adjust the indicator in the cartridge when the cartridge is loaded.The indicator provides a spring bias to the components to allow for dispensing in the loader, and lifting the indicator and allowing it to snap closed can damage the components and cartridge.Do not re-sterilize sourcelink® connectors or biospacer¿ seeding spacers either loose or in cartridges.The components are supplied sterile and indicated for single use.If desired, radioactive seeds may be removed from a cartridge and re-sterilized.Do not re-sterilize quicklink¿ cartridges.Caution: limitations on use the quicklink¿ delivery system is prescription use only.Users should be familiar with procedures and techniques involving absorbable spacers and seed train products before using the sourcelink® connectors.Sourcelink® connectors are designed to provide accurate spacing in increments of 0.5cm with typical 4.5mm brachytherapy sources.Use of sourcelink® connectors with brachytherapy sources of other lengths will result in atypical spacing.Caution: key points for use of the quicklink¿ delivery system ensure that the compression handle is fully seated to the compression slide before assembling a seed train.The gate button must remain depressed until the seed train is completely dispensed from the loader and the stylet is retracted.Ensure the lead glass door is closed prior to assembling or dispensing seed trains.Directions for use 1.Remove the protective tab from the bottom of the quicklink¿ cartridge prior to use by grasping the cartridge by the cartridge body and pulling the tab out of the side of the cartridge.To prevent inadvertent dispensing of a component, do not hold the cartridge body by the green plunger when removing the tab.2.Insert the cartridges containing seeds, sourcelink® connectors, and biospacer¿ seeding spacers into the carriage.Ensure that the cartridges are fully seated in the carriage receptacle.The carriage and cartridges are marked as follows to indicate the correct placement of cartridges as well as the current selection: radioactive implant seed quicklink¿ cartridge 5.5mm standard sourcelink® cartridge 5.0mm extension sourcelink® cartridge 0.5mm seed-to-seed sourcelink® cartridge biospacer¿ seeding spacer cartridge 3.Retract the compression slide handle to the right until it contacts the rear plate to seat the slide compression mechanism (if unseated).4.Attach the implant needle to the quicklink¿ delivery system by pushing the needle hub firmly onto the needle adapter.5.Move the carriage to select which item to dispense by aligning the indicator with the symbol indicating the desired item.Note: the position of the extension sourcelink® connector in the cartridge is accurately represented by the icon.Therefore, when spacing at either end of a seed train is desired, an extension sourcelink® connector may only be used at the leading end of the train.Spacing at the trailing end of the train must be provided by one or more spacers.6.Push the dispense button to dispense and move the selected item into the assembly track.Note: during normal operation, the dispense button will return to the ¿up¿ position after a component is dispensed.If a cartridge is empty, the button will come to a stop before it reaches the bottom of its range of motion.Further pressing will cause the button to release from its internal mechanism to prevent damage to the cartridge.The button may be lifted to the ¿up¿ position to reseat it to the internal mechanism, and the empty cartridge may be removed and replaced.Note: the dispense mechanism is designed to completely dispense a single component once depressed.The button must be pressed through its complete range of motion ¿ if the button is only pressed partially down, it will remain in the midrange position and prevent carriage motion or further dispensing.Complete the compression of the button to dispense the selected component and release the carriage for further dispensing.7.Repeat items 4-5 until all items necessary to build the predetermined seed train have been dispensed.8.Visually inspect the dispensed components, if desired, through the lead glass door prior to assembly of the seed train.Incorrect components can be removed as necessary by opening the lead glass door to access the assembly track.Note: if desired, the carriage mechanism may be removed from the loader to inspect the area beneath the carriage.To remove the carriage, depress the carriage release button while lifting the carriage upward.To replace, align the two latch prongs on the underside of the carriage with the corresponding receptacles in the loader and snap the carriage into place.9.Move the carriage to the arrow symbol indicating that the quicklink¿ delivery system is ready to either compress or dispense a seed train.10.Move the handle on the releasable slide left towards the carriage to compress the seed train.Continue motion in this direction until the slide handle releases and comes to a full stop.11.Retract the slide to the right until it contacts the rear plate to seat the slide compression mechanism.12.The assembled seed train may be inspected through the lead glass door, and proper seed spacing confirmed using the assembly base ruler.13.Move the handle on the releasable slide left again towards the carriage while holding the gate button down in order to dispense the seed train through the needle adapter.14.Retract the handle of the releasable slide fully to the right.15.Remove the loaded implant needle by pulling the needle hub away from the needle adapter.".
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