MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 30-401LITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 09/09/2019

Event Type  Death  

Event Description

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.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9686408
• MDR Text Key: 178335561
• Report Number: 9686408
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26280 DA