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Model Number VC-10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The cause of reported event cannot be determined at this time.The vc-10 instruction manual warns users "do not apply excessive force while using the cannulas and f-sets.Excessive pushing, bending, or pulling could result in injury to the patient and/or breakage of the device." as part of or investigation, olympus followed up with the user facility regarding the reported event and limited information was provided.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint.If additional information becomes available, this report will be updated and supplemented accordingly.
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Event Description
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Olympus was informed that the user facility performed 21 dilation and curettage (d&c) procedures between (b)(6) 2017 to present.Of that, four patients developed intrauterine hematomas and presented to the emergency room for treatment.In addition, patient 1 and patient 2 experienced heavy bleeding, patient 3 experienced pain with cramping and patient 4 developed a hematometrium.All four patients were managed under outpatient care.This is 2 of 4 reports.
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Search Alerts/Recalls
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