The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.The product lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint records.The labeling does address the potential for such an event in the instruction-for-use (ifu) with statements such as the following: "do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endotherapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory." (b)(4).
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