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The reported event was unconfirmed since the problem could not be reproduced.Based on the evaluation, the loader operated as normal.It was noted that the quick release plate was slightly out of position, and handle was replaced by the user with a custom part.The root cause for this failure mode was unknown.The alleged issue was not confirmed.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: "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.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 caution: storage requirements are temperature dependent extra care should be taken to avoid exposing the quicklink¿ cartridges containing bio absorbable 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.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.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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