MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE 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 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.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.

Event Description

It was reported that scope was inserted but it was noticed that the pressure was not holding well.The physician cut pathology for a brief moment and the hologic representative notified the physician that the fluid deficit was rising.The device was removed and it was noted there was a perforation at the top of the uterus.The perforation was treated with surgiflo and cautery ending deficit was 1217 with no signs of fluid overload.Patient was recovering well at the time of this report.No additional details available.

• Brand Name: MYOSURE 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
• MDR Report Key: 10574936
• MDR Text Key: 208209896
• Report Number: 1222780-2020-00125
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045504534
• UDI-Public: (01)35420045504534(17)230228(10)20B28RB
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2020

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: 02/28/2023
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 20B28RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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; Required Intervention