BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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Model Number FG-0202 |
Device Problem
Contamination (1120)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2018 that a symphion fluid management accessory device was opened to be used in a hysteroscopy procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the fma device was dropped by the surgical tech and got contaminated.The procedure was completed with another symphion fluid management accessory device.There were no patient complications as a result of the event.The patient condition at the conclusion of the procedure was reported to be fine.
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