The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use and an indention in the teflon pad was identified.The blade showed signs of melted debris which appeared to be a drape.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root causes may be attributed to: tissue accumulation between the blade and shaft.Prolonged activation (in general or against solid surfaces), repeated use of instrument beyond intended use.User selects improper min generator settings.User activates on max instead of min.Ancillary equipment error (e.G.Handpiece and/or generator).The instructions for use (ifu) state: ¿a thorough understanding of the principals and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device¿¿ ¿the entire exposed blade tip and any exposed blade shaft are active and will cut/coagulate tissue when the instrument is activated.Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue when using the instrument.¿ ¿during and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft may be hot, avoid unintended contact with tissue, drapes, surgical gowns, at all times." the reported event will continue to be monitored through post-market surveillance.
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