The customer reported that at the end of endoscopic surgery for transurethral resection for prostatic adenoma (weighing around 50 gm) a violent intravesical explosion of a probable gaseous nature occurred during the use of clot current.The procedure was immediately stopped, and exploratory laparotomy was required, revealed endo peritoneal laceration of the bladder.Reportedly, the bladder was completely ruptured with bleeding and intravesical displacement of intestinal loops with some ecchymosis.As such, complex exploratory surgery was performed to repair the bladder.Post surgery, the patient was transferred to the intensive care unit for further care.Upon follow-up no additional information could be received regarding the patient's current condition.There was 6 devices involved in this event reported under the following patient identifiers: related patient identifier# (b)(6), hf unit "esg-400", model- a42021a, serial # (b)(6).Related patient identifier# (b)(6), outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable, model- wa2t430a, serial #(b)(6).Related patient identifier # (b)(6), telescope "oes elite", 4 mm, 30°, hd, autoclavable, model- wa2t430a serial # (b)(6).Related patient identifier # (b)(6), resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs, model- a42011a, serial # unknown.Related patient identifier # (b)(6), working element, passive, for resection in saline, model- wa22367a, serial # unknown.Related patient identifier # (b)(6), hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 30°, sterile, single use, 12 pcs., for turis model- wa22306d, serial #(b)(6)(this report).
|