The user facility reported that the wire loop became partially detached from the drive cable of the device, however the wire loop component remained connected to the device.No component of the device was retained.There have been no other complaints associated with this lot.The instructions for use include the following statements: "closing or retracting the handle too tightly may cause damage to the device's flat wire.Do not exert excessive "bending" pressure on the open (deployed) device; doing so may disfigure either the flat wire and/or the wire frame's shape.The following conditions may not allow the roth net device to function properly: (1) advancing the handle to the open position with too much speed or force, (2) attempting to pass or open the device in an extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position and/or (4) actuating the device when the handle is at an acute angle in relation to the sheath.Continuous gentle traction should be applied on the handle to keep the roth net device closed.Excess pressure may cause the net to rupture or tear." the user facility has declined offer of in-service.
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