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

Model Number 10-401FC

Device Problem Insufficient Information (3190)

Patient Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 07/18/2022

Event Type  Injury  

Event Description

It was reported that during a myosure procedure on an unknown date, the pathology report came back from the procedure as fallopian tube and bowel.No additional information was provided.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15160557
• MDR Text Key: 297207983
• Report Number: 1222780-2022-00201
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/03/2022

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: 10-401FC
• Device Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female