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 01/13/2020

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 myosure procedure, the myosure control unit went black and needed to be reset.When the myosure device was removed from the patient the physician observed a piece of the blade was missing.The fragment was estimated to be the size of a few grains of sand, which broke off in the cavity and could not be located.It was not possible to find the fragment in the cavity via hysteroscopy.The physician notified pathology should the fragment be identified from the tissue trap.There was no injury to the patient reported at the time, no medical interventions were performed.Pathology confirmed that the metal fragment from the blade was found within the tissue trap.

Manufacturer Narrative

Device received and visually inspected only for reported complaint.Visual examination showed evidence of blade exit during procedure.Blade fragmentation and other blade damage locations along blade edge noted with a strike mark/gouge on cutting window rim in the 12 o'clock position observed.Findings indicate excessive force applied to device during biospy, which likely caused reported issue.This observation will be monitored and trended.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9678555
• MDR Text Key: 178124665
• Report Number: 1222780-2020-00026
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 35420045504534
• UDI-Public: (01)35420045504534(10)19J24RB
• Combination Product (y/n): N
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 19J24RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2020
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT, SN UNKNOWN