The omni surgical system device that was used by the surgeon and which a separation of the polymeric microcatheter from the device occurred was returned and evaluated by sight sciences engineers.An analysis of historical customer complaints showed that this failure mode has not previously occurred with this specific design (i.E., catalog/model #: 1-102).A review of the manufacturing records did not reveal any anomalies or other potential root causes of this complaint.The engineers examined the returned device and it appeared to function as expected, in accordance with required specifications.The stainless steel cannula is designed with a sharpened tip and was likely associated with the "separation" of the polymeric microcatheter; however, the dimensional and surface finish characteristics of the cannula were within specification, having the intended design for contact interface with the polymeric microcatheter.The "separated" microcatheter was closely examined and appeared to have been stretched and torn and possibly cut, although it did not appear to be a clean "severed" cut by the sharp cannula.The root cause could not be determined.Two potential root causes are (1) a minor defect in the microcatheter (such as a cut or hole), either created during manufacturing or in actual use of the device, became caught on the sharp stainless-steel cannula tip and tore a portion of the microcatheter from the device, or (2) the surgeon may have applied a technique during the trabeculotomy procedure that inadvertently kinked the microcatheter, causing it to orient in a sharp angle relative to the stainless-steel cannula and was subsequently stretched and ultimately severed by the cannula.The surgeon was able to easily visualize the severed microcatheter and quickly retrieve it with forceps.The patient was reported to be in "very good" condition at the conclusion of the procedures.
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On (b)(6) 2020, the surgeon was treating the right eye of a (b)(6) year-old female patient with the omni surgical system (catalog #: 1-102, lot #: 1008143).Upon completing a trabeculotomy of the second hemisphere of schlemm's canal, the microcatheter "disconnected from the device" and was freely in the anterior chamber of the patient's eye.The surgeon removed the piece of the microcatheter with forceps.After the procedure, the patient's condition was reported as "very good.".
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