It was reported that, during a knee arthroscopy, the blade leaked a substance similar to grease that left a residue on the patient tissue.It was not possible to remove such residue.A back-up device was available to complete the procedure without delay.The patient has not been stated to be injured.
|
One 72203013 4.5mm incisor plus platinum blade used for treatment, was not returned for evaluation.The complaint stated: ¿the blade leaked a substance similar to grease that left a residue on the patient tissue.¿ due to product unavailability, physical evaluation, full investigation and conclusions were not possible.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use confirms instructions, recommendations and precautionary statements and for proper use of product.To produce a device with less friction, silicone is used along with a silver plating process for additional lubrication between inner and outer blades.The silver plate surface may become discolored from silver tarnish.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.Platinum improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.The red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.The silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.This observation is monitored through surveillance.Complaint history lot review found other complaints of this nature.Product met specifications upon release to distribution.Without photos of the affected tissue, the root cause could not be definitively concluded; however, it is highly likely that the reported residue was the biocompatible silicone lubricant applied during manufacturing.No patient impact is anticipated from the reported events.Should clinically relevant documentation become available, the medical investigation task may be re-evaluated.
|