MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 50-250XL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 50-250XL manufactured by Hologic, Inc.

Event Text Entries

[184386722] Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[184386723] It was reported that during the procedure, the physician noticed small metal fragments in the uterus. They had to spend time to remove the fragments from the patient. The device was inspected after the procedure and there were no significant signs of damage to the scope that would account for the metal fragments. There were no adverse effects reported and the patient was discharged as planned. No additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00061
MDR Report Key9862965
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-02-28
Date of Event2020-02-27
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKELSEA LYVER
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH, MA
Manufacturer CountryUS
Manufacturer Phone2636130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Generic NameUTERINE TISSUE REMOVAL SYSTEM
Product CodeHIH
Date Received2020-03-20
Model Number50-250XL
Catalog Number50-250XL
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH, MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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