BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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Model Number FG-0201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 01/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device has been 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)(4) 2019 that a symphion resecting device was used during a hysteroscopy, dilatation and curettage, polypectomy procedure in the uterus performed on (b)(6) 2019.According to the complainant, during the procedure, the uterus was perforated while resecting.The procedure was completed with the device.There were no serious injury/adverse effect to patient as a result of the event.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
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Search Alerts/Recalls
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