MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 10-401FC

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 2020-03-02 for MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 10-401FC manufactured by Hologic, Inc.

Event Text Entries

[182163570] Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known. 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. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10


[182163571] It was reported that after successful completion of a fibroid and device removal, a code blue was called. Patient was under anesthesia during the procedure. According to hologic representative, she was in the hall when the code was called and she saw hospital staff rush into the room "to work on the patient. " 911 was called. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00041
MDR Report Key9775837
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-02
Date of Report2020-02-10
Date of Event2020-02-10
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-02
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 REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Generic NameUTERINE TISSUE REMOVAL SYSTEM
Product CodeHIH
Date Received2020-03-02
Model Number10-401FC
Catalog Number10-401FC
Lot NumberUNKNOWN
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
101. Life Threatening; 2. Other 2020-03-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.