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Catalog Number LC210 |
Device Problems
Mechanical Problem (1384); Failure to Form Staple (2579); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not reported.The serial number was not provided; therefore, the manufacturing record evaluation could not be performed.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that during an unknown procedure, the clip applier didn't apply proper clips.The jaws were spoiled.User reported the clips are not broken, the clip applier didn't hold the clips.Clip applier jaws were broken so they didn't hold the clips and because the clip applier jaws were broken, it didn't make the clips hold the vein or tissue.It is unknown how procedure was completed.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).Date sent: 1/13/2021.H6: component codes: others (g07).Investigation summary the analysis results found that the lc210 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained, and deployed six clips as intended.The instrument was fully functional and conforming.The event described could not be confirmed as the device performed without any difficulties noted.Although there is no direct evidence of use error, the instructions for use do contain the following caution: select the appropriate size ligaclip extra ligating clip cartridge and corresponding clip applier.With the cartridge slots facing away from the base, insert the cartridge into one of the channels openings of the lc800 stainless steel cartridge base.Ensure that the cartridge is past the channel opening and securely held in place.Grasp the applier in the box lock area using pencil grip technique.Insert the jaws of the instrument into the individual cartridge slot, making sure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Keeping the applier jaws perpendicular to the surface of the cartridge, retract the applier from the cartridge.The clip will be securely held in the applier jaws.It is not necessary to maintain ring tension to hold the clip in the applier jaws.Position the clip around the tubular structure to be ligated.Apply sufficient force to fully close the applier to assure that the clip is satisfactorily placed and secured.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.The serial number history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. the certificate records are accessible through external manufacturing. .
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Search Alerts/Recalls
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