MYOSURE TISSUE REMOVAL DEVICE 30-401LITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for MYOSURE TISSUE REMOVAL DEVICE 30-401LITE manufactured by Hologic, Inc.

Event Text Entries

[178335561] Female patient that came in for a same-day surgery-hysteroscopy for post-menopausal bleeding. She was in the or from 1100 -1250 and had removal of an endometrial mass and d&c. The aquilex fluid management system was used for irrigation and there was a "fluid deficit"/retention of 2194 mls of irrigant and noted small uterine perforation during the case. She was initially stable overnight with increasing abdominal pain and then became acutely hypotensive, progressing quickly to requiring 3 pressors. At that point, general surgery took her to or for exploratory laparoscopy and was found to have a small bowel perforation with extensive feculent material in the abdomen. She remained maxed on 3 pressors, acidotic despite crrt and coded with return of spontaneous circulation. Condition continued to deteriorate and patient expired two days post surgery. No malfunction of the device was noted or suspected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9686408
MDR Report Key9686408
Date Received2020-02-10
Date of Report2020-01-21
Date of Event2019-09-09
Report Date2020-01-21
Date Reported to FDA2020-01-21
Date Reported to Mfgr2020-02-10
Date Added to Maude2020-02-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMYOSURE TISSUE REMOVAL DEVICE
Generic NameHYSTEROSCOPE (AND ACCESSORIES)
Product CodeHIH
Date Received2020-02-10
Model Number30-401LITE
Catalog Number30-401LITE
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-10

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