It is reported by the customer (and in mw5099333), during a loop electrical excision procedure (leep)/hysteroscopic polypectomy/removal of intrauterine device (iud) using a 5fr grasper forceps, the tip broke off during the procedure.The physician decided to use hysteroscopy graspers due to the iud being embedded in the myometrium upon visualization with the hysteroscopy.The grasper was introduced through the hysteroscope in the usual fashion and after 2-3 attempts to grasp the iud, the graspers upon withdrawal from the hysteroscope, were noted to have a device failure one side of the grasper was noted to be missing.There was no evidence of any retained instrument in the uterus; however, the small metal paddle part was never identified.A second pair of graspers were then introduced and used to dislodge the iud, which was delivered without difficulty.A full and thorough hysteroscopic evaluation of the uterine cavity was performed.There was no evidence of any retained instrumentation and a full survey was performed.The patient patient was copiously irrigated and all fluid was strained after the procedure.The patient has had no adverse effects as a result of this occurrence.
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This report is being updated to provide investigation findings.The original equipment manufacturer (oem) could not provide a device history record (dhr) or udi due to the device being manufactured in 2006, therefore, (dhr) for the complaint device could not be reviewed.The definitive cause of the reported issue could not be established.Olympus will continue to monitor complaints for this device through regular trending activities and take action if triggered by olympus qms procedure.
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