Received 1 used c-max cutting loop with the original unit packaging.Visual inspection noted that the cutting loop broke off on one side.No pieces of the cutting loop appeared to be missing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed with an unknown root cause.The instructions for use state the following: "¿ the bard® c-max¿ cutting loop device should be used only by a physician who is familiar with the use of electrosurgical instruments, devices and power generators.Consult the medical literature regarding techniques, typical power settings, complications, and hazards prior to any endoscopic procedure.¿ during application of electrical energy, movement of the tip is required to achieve the desired tissue effect.¿ the monopolar electrosurgical generator should be set to the cut or pure cut mode for maximum tissue removal effect.Do not use the blend mode and be cautious of arcing on high coagulation power settings.¿ immediately discontinue use if breaks or fractures appear in the bard® c-max¿ cutting loop device.Breaks or fractures may allow undirected emission of electrical energy, rendering the device useless and potentially causing harm to surrounding tissues.¿ do not bend or manipulate the device.¿ care should be taken to avoid severe impacts, side stresses or bends at sharp angles." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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