Two (2) 000150 marked spring tip guidewires have been returned to the conmed quality assurance laboratory for evaluation regarding a complaint of guidewire "kinked." the two (2) devices were from two (2) different procedures but the identification of the individual procedures were not distinguished.Both devices were examined in the laboratory; a visual inspection noted the spring tips of the two devices are bent.The device designated as #1 was found with two (2) bends in the spring; one in the proximal soldered portion and one in the tightly wound unsoldered portion.The device designated as #2 was found with one single bend in the proximal soldered portion.Both devices appear deformed from excessive force with no evidence of manufacturing defects.The forces produced by the use have fractured the soldered coils and bent the unsoldered coils.The complaint is confirmed.The damage appears to be user related.This lot was manufactured on 6-dec-2016.Of the lot containing (b)(4) units, these two (2) devices returned to conmed are the only reported complaints for "bent" or "kinked".A 2-year review of the device complaint history showed eleven (11) similar complaints received for "bent" or "kinked" spring tip, including this reported event.During this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode 0.05 percent.This failure mode is addressed in the risk document with an acceptable risk level.No evidence of manufacturing or material defects were observed.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.No further investigation is planned at this time; however, the reported complaint issue will continue to be monitored through the complaint system.The marked spring tip guidewire is a nonsterile, reusable 210 cm long solid metal mandrel with a flexible variable thread spring attached to it.The guidewire is to be used with american dilators and is compatible with key med, savary, eder puestow, and celestin esophageal systems.To reduce the risk of the spring tip bend and/or breakage, and to reduce patient injury, the ifu provides the following warnings: "the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action." "carefully inspect the guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.".
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The user facility reported that on (b)(6) 2017 the "doctor performed a savory dilation of esophagus and utilized the conmed marked spring tip guidewire to guide the savory dilator, but the guidewire kinked." follow-up communication with the nurse manager revealed that the cases were over a month ago and she has no idea who the patients were, therefore can not provide any patient information.In addition, the procedures were completed with the use of a dilator that did not require a guidewire.There was no patient or user injury with this reported incident.To date there has been no additional information received regarding the patient's latest condition or any indication that long term adverse effect has occurred.This report is filed on the basis of potential injury with recurrence.While gathering further information from the user facility, conmed was made aware that there was another similar incident with a different patient on (b)(6) 2017.(this incident will be reported under number 3007305485-2017-00042).
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