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.
[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
Report Number | 9686408 |
MDR Report Key | 9686408 |
Date Received | 2020-02-10 |
Date of Report | 2020-01-21 |
Date of Event | 2019-09-09 |
Report Date | 2020-01-21 |
Date Reported to FDA | 2020-01-21 |
Date Reported to Mfgr | 2020-02-10 |
Date Added to Maude | 2020-02-10 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MYOSURE TISSUE REMOVAL DEVICE |
Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
Product Code | HIH |
Date Received | 2020-02-10 |
Model Number | 30-401LITE |
Catalog Number | 30-401LITE |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | 1 DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HOLOGIC, INC |
Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death | 2020-02-10 |