BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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Model Number M006580211 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2015 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a genesys hydrothermablation (hta) procerva procedure set was opened for use during a hydrothermablation (hta) procedure performed on (b)(6), 2015.According to the complainant, during preparation, they noticed a strand of hair underneath the tubing inside the sterile sheath assembly packaging.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition was reported to be "fine.".
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Manufacturer Narrative
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(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.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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