A user facility reported to olympus that while using the versapoint ii electrosurgical generator, non-sterile, reusable for a myomectomy, four (4) loops were opened for the case.The first loop burned through while "activated." the surgeon managed to get the metal part out (presumably out of the body) by curetting it out and washing it out with saline under pressure.Three other loops were opened, and all burned through the center of the loop before attempting to use the loop to cut.A new generator was brought in and the case was finished with a loop without any further problems.The first generator had been serviced 3 weeks prior to the case.However, when the technician went out to the facility the day after the issues were noted, the generator was on the maximum setting of 200, which was past the default setting of 170.It was stated that the staff had not changed any settings and they use the default setting.Additional information has been requested.This event requires 5 reports.(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (first loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (second loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (third loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (fourth loop).(b)(6) is for the versapoint ii electrosurgical generator, non-sterile, reusable.This mdr is for the fourth versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting.
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Additional information was obtained.The indication for the myomectomy was a large myoma found on scan.When asked how long the delay was, the user facility stated that the operation took a total of 145 minutes.They were unable to say exactly how long the delay was, but that it was probably about 3 minutes per each loop exchange.It was also stated that since it was a large fibroid, it did a long time to remove it.The anesthesiologist kept the patient sedated as per normal.The patient had no adverse effects and went home the next morning.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection and the customer's complaint was confirmed.The loop at the distal end was found broken.No electrical or functional testing was conducted.The condition of the fracture face of the device suggests a brittle failure.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, (per capa cap-100101), the root cause for this issue is likely due to a weakness in the current material strength and/or ductility.Olympus will continue to monitor field performance for this device.
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