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
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 procedure performed on (b)(6) 2018.According to the complainant, during preparation, the introducer from fluid management accessory was not package properly, it popped out and became unsterile.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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Search Alerts/Recalls
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