Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the device history record and the shipping inspection record of the involved product/lot# combination confirmed that there were not any indications of production-related problems or any nonconforming indications in the shipping inspection result.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guidewire and/or endo therapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guide wire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory.- do not insert the instrument into the endoscope or endo therapy accessory unless movements of the instrument can be observed under clear endoscopic or x-ray image.If you cannot see the distal end of the insertion potion in the endoscopic or x-ray image, do not use the instrument.Otherwise unintended movements of the instrument could cause patient injury, such as punctures, hemorrhages or mucus membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.However, based on the reproductive tests previously conducted, the guide wire may get fractured when it has been subjected to force.(b)(4).
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