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 # 5307w140009 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 (this report) 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).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the cause for the reported issue is likely a complication during the procedure.During resection, cutting and coagulation, thermal decomposition of the rinsing fluid creates a detonable mixture of gaseous hydrogen (h2) and oxygen (o2), also known as oxyhydrogen or oxyhydrogen.Activation of the rf current in the presence of flammable gases may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns, or other injuries.Since the device was not returned for inspection, and the dhr was unable to be reviewed, a definitive root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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