MAUDE Adverse Event Report: HOLOGIC, INC MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 30-401LITE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.

Event Description

It was reported that during the procedure, the blade of the device went missing.It was unknown if the blade got suctioned into the handpiece, but further investigation showed it was not there.An x-ray was performed to determine if there were any device fragments in the patient.There were no abnormalities seen on imaging studies.No additional details available at this time.

• Brand Name: MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, ma ; 2636130
• MDR Report Key: 9924160
• MDR Text Key: 186524404
• Report Number: 1222780-2020-00071
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045505074
• UDI-Public: (01)35420045505074(10)19L11RK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2020

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 Expiration Date: 11/11/2022
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 19L11RK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention