It was reported that the device was used during a laparoscopic cholecystectomy, it was reported by the rep that the head nurse stated that the surgeon had a problem with the er320 scissoring and it severed a vessel. The surgeon was able to use the clip applier again to obtain hemostasis. There was no consequence to the pt.

Sent 6/16/99. A1,2,3,4; b6,7; d10: info not provided during initial contact. Follow up letter sent to facility requesting add'l info. D6: device returned with no lot identification. Batch no: m51546, lot no: unk, qty invld: 1, warranty: no. Nature of call: question and result: clip in jaws, yes; damaged weld seams, no; damaged tube, no; damaged trigger, no; damaged floor, no; damaged other, na; jaws: inside width at tips,. 170"; firing: form conform, yes; lockout functional, yes; damaged handle shrouds, no; damaged tip shrouds, no; damaged jaws, no; damaged feed bar, no; damaged cutter, no; jaws: hold clip, yes; firing: feed conform, yes; number of clips fed and formed, 9; and antibackup functional, yes. Visual comment: one instrument was received in good physical condition and with one clip in the jaws. Functional comment: the clip was removed from the jaws. The instrument was cycled, fired 9 conforming clips and locked out. The instrument functioned as intended. Analysis conclusion: no conclusion could be reached based on the analysis results as to what may have caused the reported incident. The instrument was returned in good physical condition. The instrument was cycled, fed, and formed the remaining clips within mfg requirements when tested. The instrument was fully functional and conforming to mfg requirements.