BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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Model Number FG-0612-R |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on october 28, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on an unknown date.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.
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Manufacturer Narrative
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Block h6: problem code 1198 captures the reportable event of electrical/electronic property problem.Block h10:investigation result a symphion controller was returned for evaluation.Based on a thorough review of the complaint, they found an intermittent operation with the returned footswitch.The footswitch cable was pullin out of the male plug connector, also found corrosion on the motor pcba inside the console.The reported complaint of electrical issue was confirmed.The fault was most likely caused by unintended mishandling of the footswitch connector causing physical damage to the connector.Therefore, the most probable cause for this complaint is unintended use error caused or contributed to event which indicates that the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on an unknown date.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.
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