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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL

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BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number M006580211
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2015
Event Type  malfunction  
Event Description
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.".
 
Manufacturer Narrative
(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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Brand Name
GENESYS HTA PROCERVA®
Type of Device
DEVICE, THERMAL ABLATION, ENDOMETRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4628154
MDR Text Key5762065
Report Number3005099803-2015-00647
Device Sequence Number1
Product Code MNB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM006580211
Device Catalogue Number58021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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