MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-501XL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

Lot/serial number of the device not provided by the complainant, therefore the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.

Event Description

It was reported that during a myosure procedure performed on dec 10th, the cutting blade of the myosure device broke inside the patient due to a very dense fibroid that was being removed.The physician did not observe any debris left inside the uterine cavity.No additional intervention was needed.A new myosure device was opened and used.No injuries reported.

Manufacturer Narrative

Device received and analyzed for reported complaint.Blade assembly not visible in cutting window.Dissection of device showed blade tube assembly broken and scored near proximal end of a scored outer metal tube at the nose of the handpiece.The actual blade edge was found to be fully intact absent of any fractures or damage, but because the blade wasn't visible in the cutting window the claimant likely believed it had broken off of device.This complaint was not verified.The broken blade tube at proximal end was noted as a secondary finding and likely the result of excessive force applied to the disposable during procedure.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: MYOSURE XL TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11095844
• MDR Text Key: 224394127
• Report Number: 1222780-2020-00185
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1