MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE REACH TISSUE REMOVAL DEVICE; UTERINE TISSUE REMOVAL SYSTEM

Model Number 10-401FC

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/01/2020

Event Type  malfunction  

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 a fibroiad removal case on (b)(6) 2020 the tissue removal device made odd noises while cutting a polyp with the first myosure reach device used and the cable jumped.A second myosure reach device was used and the drive cable jumped again.The physician was able to complete the fibroid removal procedure.A post-procedure hysteroscopy was performed and discovered that there were some metal fragments of the device in the patient uterus.The metal fragments were removed successfully via hysteroscopy.The physician reported no additional impact or injury to the patient.No medical intervention was necessary to prevent further injury.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, ma ; 2638713
• MDR Report Key: 10076792
• MDR Text Key: 192024810
• Report Number: 1222780-2020-00078
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045504534
• UDI-Public: (01)35420045504534(10)20B10RP
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 20B10RP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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