BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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Model Number FG-0201 |
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 resecting device was opened to be used in a hysteroscopy/polypectomy procedure performed on (b)(6) 2018.According to the complainant, during preparation, the staff was worried about the sterility of the device because the sterile packaging did not completely tear.The procedure was completed with another symphion resecting 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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