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

Model Number 10-401FC

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

Patient Problem Uterine Perforation (2121)

Event Date 12/03/2019

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 unable to be conducted for the disposable device or the radio frequency controller as the identification numbers were not provided by the complainant.

Event Description

It was reported that during a submucosal fibroid resection procedure, the patient uterus was perforated.The perforation was noted during the final hysteroscopy and "confirmed the perforation with a diagnostic lap." no additional intervention was required.Hologic representative is unsure if the patient was discharged as planned.No additional details available.

• Brand Name: MYSOURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9512918
• MDR Text Key: 175030128
• Report Number: 1222780-2019-00287
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045504534
• UDI-Public: (01)35420045504534(10)
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 19G12R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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): Other