The account returned 1 ethmcl20 stating "clips did not fire correctly" and that a vessel was severed during the devices use in the procedure.The device was examined, and it was obvious that the clips in the shaft were not advancing to the jaws for placement.The device was actuated, and despite the actuation the clips in the shaft did not change position, and the jaws would close and open, empty without a clip in them.The device was shipped to the field with 11 clips present in the shaft.The device was returned with only 7 remaining, and a gap between the lead clip and the jaws.Actuating the handle did open and close the jaws, though without a clip present in them.Opening and closing the jaws of the device on a vessel without a clip present in them can cause damage to the vessel upto and including the severing of that vessel.The ifu states within its warnings and precautions: 5.Upon each clip application, fully squeeze the handles of the multiple clip applier until they come to a stop.Failure to fully squeeze the handles can result in an improper formation of clips, and therefore, unsatisfactory ligation of tissue.6.Prior to each clip application, inspect the jaw tips to ensure the clip is fully advanced to the end of the jaws.If a clip is dislodged prematurely from the jaws or fails to advance, re-fire the multiple clip applier by fully squeezing the handles until they stop.Fully release the handles to advance the next clip into the jaws.The clip retainer was not in position on the returned device.In its current condition it is believed that the device would fire unformed clips if the remaining clips were to advance.The root cause for the clip retainer moving out of position is unknown but may be linked to the use of the device in the field.A device history record review was performed, and no discrepancies were noted.Manufacturer's ref.No: (b)(4).
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